[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Proposed Rules]
[Pages 67105-67115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26726]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2014-N-1205]
Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid
Pedicle Screw Systems; Classification and Effective Date of Requirement
for Premarket Approval for Dynamic Stabilization Systems
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing in this
administrative order to reclassify rigid pedicle screw systems, a
[[Page 67106]]
preamendments class III device, into class II (special controls);
require the filing of a premarket approval application (PMA) or a
notice of completion of a product development protocol (PDP) for the
dynamic stabilization systems, currently a subtype of pedicle screws,
regardless of the indication for use; and clarify the device
identification of pedicle screw spinal systems, to more clearly
delineate between rigid pedicle screw systems and dynamic stabilization
systems. FDA is proposing this action based on new information
pertaining to the device type. This proposed action implements certain
statutory requirements.
DATES: Submit either electronic or written comments on this proposed
order by February 10, 2015. FDA intends that, if a final order based on
this proposed order is issued, anyone who wishes to continue to market
dynamic stabilization systems for the specified intended uses listed in
section IX will need to file a PMA or a notice of completion of a PDP
within 90 days of the effective date of the final order. See section
XVII for the proposed effective date of any final order based on this
proposed order.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-1205, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (For paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1205 for this order. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sergio M. de del Castillo, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-
796-6419, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act of 2004
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type may be marketed by means of premarket
notification procedures (510(k) process) without submission of a PMA
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval.
Although, under the FD&C Act, the manufacturer of a class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a PDP, in practice, the option of filing a
notice of completion of a PDP has not been used. For simplicity,
although corresponding requirements for PDPs remain available to
manufacturers in response to a final order under section 515(b) of the
FD&C Act, this document will refer only to the requirement for the
filing and receiving approval of a PMA.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended the device reclassification procedures under section 513(e) of
the FD&C Act, changing the process for reclassifying a device from
rulemaking to an administrative order. Section 608(b) of FDASIA amended
section 515(b) of the FD&C Act, changing the process for requiring
premarket approval for a preamendments class III device from rulemaking
to an administrative order.
A. Reclassification
Pedicle screw spinal systems comprise multiple different device
types:
Pedicle screw spinal systems (i.e., rigid pedicle screw systems)
when intended to provide immobilization and stabilization of spinal
segments in the thoracic, lumbar, and sacral spine as an adjunct to
fusion in the treatment of degenerative disc disease (DDD) and
spondylolisthesis (other than either severe spondylolisthesis (grades 3
and 4) at L5-S1 or degenerative spondylolisthesis with objective
evidence of neurologic impairment) are class III preamendment devices.
Dynamic stabilization systems (DSSs), when intended to provide
[[Page 67107]]
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
DDD and spondylolisthesis (other than either severe spondylolisthesis
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with
objective evidence of neurologic impairment), are also class III
preamendment devices.
DSSs, when intended to provide immobilization and stabilization of
spinal segments in the thoracic, lumbar, and sacral spine as an adjunct
to fusion in the treatment of any of the following acute and chronic
instabilities or deformities of the thoracic, lumbar, and sacral spine:
Severe spondylolisthesis (grades 3 and 4) at L5-S1; degenerative
spondylolisthesis with objective evidence of neurologic impairment;
fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed
previous fusion (pseudarthrosis), are class II devices.
FDA is proposing the reclassification of pedicle screw systems
(i.e., rigid pedicle screw systems) when intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
DDD and spondylolisthesis (other than either severe spondylolisthesis
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with
objective evidence of neurologic impairment) from class III to class
II.
When intended to provide immobilization and stabilization of spinal
segments in the thoracic, lumbar, and sacral spine as an adjunct to
fusion in the treatment of DDD and spondylolisthesis (other than either
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment),
the Agency proposes maintaining DSSs in class III. The Agency also
proposes that DSSs be reclassified from class II to class III when
intended to provide immobilization and stabilization of spinal segments
in the thoracic, lumbar, and sacral spine as an adjunct to fusion in
the treatment of any of the following acute and chronic instabilities
or deformities of the thoracic, lumbar, and sacral spine: Severe
spondylolisthesis (grades 3 and 4) at L5-S1; degenerative
spondylolisthesis with objective evidence of neurologic impairment;
fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed
previous fusion (pseudarthrosis). As a result, FDA is proposing that
all currently marketed DSSs be class III and now require a submission
of a PMA.
Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland Rantos v.
United States Department of Health, Education, and Welfare, 587 F.2d
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell v. Goddard, supra 366
F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C.
1991)), or in light of changes in ``medical science'' (Upjohn, 422 F.2d
at 951). Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and Sec. 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S.
1062 (1985).)
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)
Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments from all affected stakeholders, including
patients, payors, and providers. In addition, the proposed order must
set forth the proposed reclassification, and a substantive summary of
the valid scientific evidence concerning the proposed reclassification,
including the public health benefits of the use of the device, and the
nature and incidence (if known) of the risk of the device. (See section
513(e)(1)(A)(i) of the FD&C Act.)
Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. FDA has considered rigid pedicle screw systems and decided
that the device requires premarket notification (510(k) of the FD&C
Act). Therefore, the Agency does not intend to exempt this proposed
class II device from premarket notification (510(k)) submission as
provided under section 510(m) of the FD&C Act.
B. Requirement for Premarket Approval Application
FDA is proposing to require PMAs for DSSs when intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
any of the following indications for use: DDD; spondylolisthesis;
degenerative spondylolisthesis with objective evidence of neurologic
impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor;
and failed previous fusion (pseudarthrosis). Section 515(b)(1) of the
FD&C Act sets forth the process for issuing a final order.
Specifically, prior to the issuance of a final order requiring
premarket approval for a preamendments class III device, the following
must occur: (1) Publication of a proposed order in the Federal
Register; (2) a meeting of a device classification panel described in
section 513(b) of the FD&C Act; and (3) consideration of comments from
all affected stakeholders, including patients, payors, and providers.
FDA has held a meeting of a device classification panel described in
section 513(b) of the FD&C Act with respect to DSSs, and therefore, has
met this requirement under section 515(b)(1) of the FD&C Act. As
explained further in section X, a meeting of the device classification
panel described in section 513(b) of the FD&C Act took place in 2013
(Ref. 1) to discuss whether DSSs should be reclassified or remain in
class III. The panel recommended that DSSs should be classified as
class III when intended to provide immobilization and stabilization of
spinal segments in the thoracic, lumbar, and sacral spine as an
[[Page 67108]]
adjunct to fusion in the treatment of any of the following indications
for use: DDD; spondylolisthesis; degenerative spondylolisthesis with
objective evidence of neurologic impairment; fracture; dislocation;
scoliosis; kyphosis; spinal tumor; and failed previous fusion
(pseudarthrosis). Section 515(b)(2) of the FD&C Act provides that a
proposed order to require premarket approval shall contain: (1) The
proposed order, (2) proposed findings with respect to the degree of
risk of illness or injury designed to be eliminated or reduced by
requiring the device to have an approved PMA or a declared completed
PDP and the benefit to the public from the use of the device, (3) an
opportunity for the submission of comments on the proposed order and
the proposed findings, and (4) an opportunity to request a change in
the classification of the device based on new information relevant to
the classification of the device.
Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later. For DSSs, the
preamendments class III devices that are the subject of this proposal,
the later of these two time periods is the 90-day period. Because these
devices were classified in 1998, the 30-month period has expired (63 FR
40025, July 27, 1998). Therefore, if the proposal to require premarket
approval for DSSs for the uses described above is finalized, section
501(f)(2)(B) of the FD&C Act requires that a PMA for such device be
filed within 90 days of the date of issuance of the final order. If a
PMA is not filed for such device within 90 days after the issuance of a
final order, the device would be deemed adulterated under section
501(f) of the FD&C Act.
DSSs are currently cleared in either one of two classifications--
class II or class III--depending on the indications for use. Therefore,
two separate actions are proposed in this proposed order. For those
DSSs that are currently class II, the Agency is proposing to reclassify
these devices to class III and to require submission of a PMA. For
those DSSs that are preamendments class III, the Agency is proposing to
maintain these devices in class III and to require submission of a PMA.
As stated in the preceding paragraph, for those DSSs that are
preamendments class III devices, if the proposal to require premarket
approval for DSSs is finalized, section 501(f)(2)(B) of the FD&C Act
requires that a PMA for such a device be filed within 90 days of the
date of issuance of the final order. However, for reasons discussed
below, FDA does not intend to ensure compliance with the 90-day
deadline for PMA submission, for those DSSs that are currently in class
III (for further discussion see sections IX and XII). Also, a
preamendments device subject to the order process under section 515(b)
of the FD&C Act is not required to have an approved investigational
device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous
with its interstate distribution until the date identified by FDA in
the final order requiring the filing of a PMA for the device. At that
time, an IDE is required only if a PMA has not been filed. If the
manufacturer, importer, or other sponsor of the device submits an IDE
application and FDA approves it, the device may be distributed for
investigational use. If a PMA is not filed by the later of the two
dates, and the device is not distributed for investigational use under
an IDE, the device is deemed to be adulterated within the meaning of
section 501(f)(1)(A) of the FD&C Act, and subject to seizure and
condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its
distribution continues. Other enforcement actions include, but are not
limited to, the following: shipment of devices in interstate commerce
may be subject to injunction under section 302 of the FD&C Act (21
U.S.C. 332), and the individuals responsible for such shipment may be
subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333). In the past, FDA has requested that manufacturers take action to
prevent the further use of devices for which no PMA has been filed and
may determine that such a request is appropriate for the class III
devices that are the subject of this proposed order, if finalized.
In accordance with section 515(b)(2) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of DSS for the uses described previously.
II. Regulatory History of the Device
In 1998, FDA issued a final rule classifying pedicle screw spinal
systems as class II devices, when intended to provide immobilization
and stabilization of spinal segments in the thoracic, lumbar, and
sacral spine as an adjunct to fusion in the treatment of degenerative
spondylolisthesis with objective evidence of neurologic impairment,
fracture, dislocation, scoliosis, kyphosis, tumor, and failed previous
fusion (63 FR 40025). For all other indications for use, pedicle screw
spinal systems were deemed class III, for which a PMA is required.
Classification of these devices followed the recommendations of the
August 20, 1993, and July 22, 1994, meetings of the Orthopedic and
Rehabilitation Devices Panel (the Panel). The Panel considered the
reclassification of pedicle screw spinal systems for all indications,
and recommended that FDA reclassify only certain indications into class
II, leaving the other indications, including those of the devices that
are the subject of this order, as class III devices (60 FR 51946,
October 4, 1995).
In 2001, a technical amendment was published in the Federal
Register to correct several errors and omissions in the July 27, 1998,
final rule (66 FR 28051, May 22, 2001).
The Agency identified the omission of one indication for
use within the list of class III uses for pedicle screw spinal
systems--the treatment of severe spondylolisthesis (grades 3 and 4) at
the L5-S1 level as an adjunct to fusion. This indication was found to
fall under preamendments status because devices were marketed for this
indication prior to 1976.
DDD and spondylolisthesis other than severe
spondylolisthesis (grades 3 and 4) at L5-S1 were erroneously identified
as postamendment uses, when in fact these are preamendment uses. While
this error did not affect the final classification of the device for
these uses (i.e., class III), it did affect the type of premarket
submission required. Because these are preamendment uses, a PMA is not
required until the Agency issues a final order under section 515(b) of
the FD&C Act (21 U.S.C. 360e(b)) requiring submission of PMAs. Until
that time, the devices may enter the
[[Page 67109]]
market after clearance of a premarket notification (510(k)) submission.
DDD and spondylolisthesis (other than either severe
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment)
were the only class III uses specifically discussed by the panel during
the August 20, 1993, and July 22, 1994, panel meetings. Therefore, the
classification regulation was amended to state that pedicle screw
spinal systems are deemed class III only for these specific uses.
In 2009, FDA published an order under section 515(i) of the FD&C
Act (21 U.S.C. 360i) to call for information on the remaining class III
510(k) preadmendment device, including pedicle screw spinal systems
when intended to provide immobilization and stabilization of spinal
segments in the thoracic, lumbar, and sacral spine as an adjunct to
fusion in the treatment of DDD and spondylolisthesis (other than either
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment) (74
FR 16214, April 9, 2009). In response to that order, FDA received
information from several device manufacturers who all recommended that
pedicle screw spinal systems described in the preceding sentence should
be reclassified to class II. The manufacturers stated that safety and
effectiveness of these devices may be assured via special controls,
including labeling, biocompatibility, sterility, and mechanical
testing.
A meeting of the Orthopedic and Rehabilitation Devices Panel was
convened on May 22, 2013 (2013 Panel). The 2013 Panel recommended that
rigid pedicle screw systems should be classified as class II when
intended to provide immobilization and stabilization of spinal segments
in the thoracic, lumbar, and sacral spine as an adjunct to fusion in
the treatment of DDD and spondylolisthesis (other than either severe
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment).
The special controls discussed by the 2013 Panel included those
proposed by device manufacturers in response to the 2009 order; as well
as an additional control proposed in this order of design
characteristics. The 2013 Panel also recommended that DSSs, a subset of
pedicle screw spinal systems, be classified as class III when intended
to provide immobilization and stabilization of spinal segments in the
thoracic, lumbar, and sacral spine as an adjunct to fusion, regardless
of the indications for use, requiring submission of a PMA. FDA is not
aware of new information that would provide a basis for a different
recommendation or finding.
III. Device Description
Pedicle screw spinal systems (i.e., rigid pedicle screw systems)
are multiple component devices made from a variety of materials that
allow the surgeon to build an implant system to fit the patient's
anatomical and physiological requirements. Such a spinal implant
assembly may consist of a combination of hooks, screws, longitudinal
members (e.g., plates, rods, plate/rod combinations), transverse or
cross connectors, and interconnection mechanisms (e.g., rod-to-rod
connectors, offset connectors). Rigid pedicle screw systems provide
immediate rigid fixation to the spinal column as an adjunct to spinal
fusion procedures.
Since the 1998 final classification, changes in technological
characteristics have occurred, leading to the emergence of a new type
of pedicle screw spinal system, known as DSSs. DSSs are a subset of the
pedicle screw spinal systems regulated under Sec. 888.3070 (21 CFR
888.3070). DSSs are defined as systems that contain one or more non-
uniform and/or non-metallic longitudinal elements (e.g., polymer cords,
moveable screw heads, springs) that allow more motion or flexibility
(e.g., bending, rotation, translation) compared to rigid systems and do
not provide immediate rigid fixation to the spinal column as an adjunct
to spinal fusion procedures.
FDA is proposing to modify the identification language from the way
it is presently written in Sec. 888.3070(a) to include this technology
and is also seeking comments on alternative means of providing further
distinction between rigid pedicle screw systems and DSSs.
IV. Proposed Reclassification
FDA is proposing that rigid pedicle screw systems subject to this
order be reclassified from class III to class II. In this proposed
order, the Agency has identified special controls under section
513(a)(1)(B) of the FD&C Act that, together with general controls
(including prescription use), would provide reasonable assurance of
their safety and effectiveness. Absent the special controls identified
in this proposed order, general controls applicable to the device are
insufficient to provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, in accordance with sections 513(e) and 515(i) of the
FD&C Act and Sec. 860.130, based on new information with respect to
the devices and taking into account the public health benefit of the
use of the device and the nature and known incidence of the risk of the
device, FDA, on its own initiative, is proposing to reclassify this
preamendments class III device into class II when intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
DDD and spondylolisthesis (other than either severe spondylolisthesis
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with
objective evidence of neurologic impairment). FDA believes that this
new information is sufficient to demonstrate that the proposed special
controls can effectively mitigate the risks to health identified in the
next section, and that these special controls, together with the
general controls, will provide a reasonable assurance of safety and
effectiveness for rigid pedicle screw systems intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
degenerative disc disease and spondylolisthesis other than either
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment.
Section 510(m) of the FD&C Act authorizes the Agency to exempt
class II devices from premarket notification (510(k)) submission. FDA
has considered rigid pedicle screw systems and decided that the device
requires premarket notification (510(k) of the FD&C Act). Therefore,
the Agency does not intend to exempt this proposed class II device from
premarket notification (510(k)) submission as provided under section
510(m) of the FD&C Act.
The Agency is also taking this opportunity to revise the
identification for pedicle screw spinal systems to distinguish between
rigid pedicle screw systems currently in class II and DSSs currently in
class III. The proposal calling for a PMA requirement for DSS is
discussed in section X.
In addition, the Agency is taking the opportunity to add the
following indications for use to Sec. 888.3070--spinal stenosis and
lordosis (a subset of spinal curvatures and deformities). Spinal
stenosis and lordosis are conditions that can be treated with fusion
surgery, which can include the use of rigid pedicle screw systems, and
the Agency believes that the inclusion of spinal stenosis and lordosis
in the regulation is appropriate. It is believed
[[Page 67110]]
that the risks to health listed in this document encompass the risks
associated with treating patients with both spinal stenosis and
lordosis using rigid pedicle screw systems as part of the procedure. It
is expected that the special controls identified are appropriate to
provide reasonable assurance of the safety and effectiveness for rigid
pedicle screw systems when used as an adjunct to fusion to treat spinal
stenosis and lordosis. In addition, since the 1998 final
classification, the Agency has found pedicle screw spinal systems for
the indications of spinal stenosis and lordosis substantially
equivalent to devices previously cleared under Sec. 888.3070.
V. Risks to Health
After considering available information, including the
recommendations of the advisory committee (panels) for the
classification of these devices, FDA has evaluated the risks to health
associated with the use of pedicle screw spinal systems (i.e., rigid
pedicle screw systems), when intended to provide immobilization and
stabilization of spinal segments in the thoracic, lumbar, and sacral
spine as an adjunct to fusion in the treatment of DDD and
spondylolisthesis (other than either severe spondylolisthesis (grades 3
and 4) at L5-S1 or degenerative spondylolisthesis with objective
evidence of neurologic impairment). FDA determined that the following
risks to health are associated with its use:
Device failure--Components may deform, fracture, wear,
loosen, or disassemble, resulting in a mechanical or functional
failure; this may result in back/leg pain, neurological deficit/injury,
or loss of correction.
Failure at the bone/implant interface--Components may
loosen, migrate, or disengage from the bone; this may result in back/
leg pain, neurological deficit/injury, or loss of correction.
Tissue injury--Intraoperative and post-operative risks of
tissue injury include: Bone fracture, injury to blood vessels or
viscera, neurologic injury, dural tear or cerebrospinal fluid leak and
skin penetration or irritation, post-operative wound problems including
infection, and hematoma/seroma.
Adverse tissue reactions--Device material(s) may elicit
adverse tissue reactions, such as foreign body response, metal allergy,
and metal toxicity.
Device malposition--Risks of device malposition may
include difficulty or inability to implant the device components or
incorrect placement of the device.
Pseudarthrosis--The risk of nonunion, or pseudarthrosis,
signifies failure of bony fusion and potential instability or pain.
The risks to health presented to the 2013 Panel such as cardiac,
respiratory, gastrointestinal, and death are considered general
surgical risks associated with the surgical procedure to implant rigid
pedicle screw systems (Ref. 1); these risks are not directly associated
with rigid pedicle screw systems and therefore are not included in the
above list of risks. Failure of the rigid pedicle screw system as a
result of the risks to health listed previously may result in the need
for reoperation, revision, or removal.
While presented to the 2013 Panel as a potential risk, graft
settling would not be considered a device-specific risk. Rather, it
represents a potential mechanism for the development of pseudarthrosis,
instability, or lack of correction. Further, graft settling is expected
in patients undergoing fusion surgery and does not necessarily result
in adverse clinical sequelae. Thus, this item does not appear in the
above list.
The 2013 Panel stated that the risks to health for DSSs appear
similar to those identified for rigid pedicle screw systems; however,
as discussed in section X, few data exist to confirm the risk profile
for these devices. Therefore, the risks to health cannot be fully
characterized for this device type. FDA is also seeking comments on
further characterizing the risks to health for DSSs.
VI. Summary of Reasons for Reclassification
If properly manufactured and used, FDA believes that pedicle screw
spinal systems (i.e., rigid pedicle screw systems), when intended to
provide immobilization and stabilization of spinal segments in the
thoracic, lumbar, and sacral spine as an adjunct to fusion in the
treatment of degenerative disc disease and spondylolisthesis (other
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or
degenerative spondylolisthesis with objective evidence of neurologic
impairment), should be reclassified into class II because special
controls, in addition to general controls, can be established to
provide reasonable assurance of the safety and effectiveness of the
device, and because general controls themselves are insufficient to
provide reasonable assurance of its safety and effectiveness. In
addition, there is now adequate effectiveness information sufficient to
establish special controls to provide such assurance.
VII. Summary of Data Upon Which the Reclassification Is Based
FDA believes that the identified special controls, in addition to
general controls, are necessary to provide reasonable assurance of
safety and effectiveness of rigid pedicle screw systems. Therefore, in
accordance with sections 513(e) and 515(i) of the FD&C Act and Sec.
860.130, based on new information with respect to the device and taking
into account the public health benefit of the use of the device and the
nature and known incidence of the risk of the device, FDA, on its own
initiative, is proposing to reclassify this preamendments class III
device into class II. The Agency has identified special controls that
would provide reasonable assurance of their safety and effectiveness.
Rigid pedicle screw systems are prescription devices restricted to
patient use only upon the authorization of a practitioner licensed by
law to administer or use the device.
Since the 1998 final classification, when FDA classified pedicle
screw spinal systems into class III, sufficient evidence has been
developed to support a reclassification of rigid pedicle screw systems
to class II with special controls, when such devices are intended to
provide immobilization and stabilization of spinal segments in the
thoracic, lumbar, and sacral spine as an adjunct to fusion in the
treatment of degenerative disc disease and spondylolisthesis (other
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or
degenerative spondylolisthesis with objective evidence of neurologic
impairment). FDA has been reviewing these devices for many years and
their risks are well known. The risks to health are identified in
section V, and FDA believes these risks can be adequately mitigated by
special controls.
FDA's presentation to the 2013 Panel included a summary of the
available safety and effectiveness information for rigid pedicle screw
systems for treatment of the previously described uses, including
comprehensive reviews of the available literature and adverse event
reports from the Manufacturer and User Facility Device Experience
(MAUDE) database. Based on the available safety and effectiveness
information that supports that rigid pedicle screw systems may be
beneficial for patients undergoing fusion treatment of the previously
described conditions, FDA recommended that rigid pedicle screw systems
be reclassified to class II (special controls) when such devices are
intended to provide immobilization and stabilization of spinal segments
in the
[[Page 67111]]
thoracic, lumbar, and sacral spine as an adjunct to fusion in the
treatment of degenerative disc disease and spondylolisthesis (other
than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or
degenerative spondylolisthesis with objective evidence of neurologic
impairment). The 2013 Panel discussed and made recommendations
regarding the regulatory classification of rigid pedicle screw systems
to either reconfirm to class III (subject to premarket approval
application) or reclassify to class II (subject to special controls) as
directed by section 515(i) of the FD&C Act. The 2013 Panel agreed with
FDA's conclusion that the available scientific evidence is adequate to
support the safety and effectiveness of rigid pedicle screw systems for
these uses.
The 2013 Panel also agreed with the identified risks to health
outlined in section V. The 2013 Panel also recommended that allergic
reaction to the device and its materials should be included as a risk
to health. FDA agrees with the 2013 Panel's recommendation and has
included this risk. The 2013 Panel agreed with FDA's proposed special
controls outlined in section VIII.
The 2013 Panel transcript and other meeting materials are available
on FDA's Web site (Ref. 1).
VIII. Proposed Special Controls
FDA believes that the following special controls, in addition to
general controls (including applicable prescription-use restrictions
and continuing 510(k) notification requirements), are sufficient to
mitigate the risks to health described in section V for rigid pedicle
screw systems:
The design characteristics of the device, including
engineering schematics, must ensure that the geometry and material
composition are consistent with the intended use.
Non-clinical performance testing must demonstrate the
mechanical function and durability of the implant.
Device components must be demonstrated to be
biocompatible.
Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
Labeling must specifically include the following:
[cir] A clear description of the technological features of the
device including identification of device materials and the principles
of device operation;
[cir] intended use and indications for use including levels of
fixation;
[cir] identification of magnetic resonance compatibility status;
[cir] cleaning and sterilization instructions for devices and
instruments that are provided non-sterile to the end user; and
[cir] detailed instructions of each surgical step, including device
removal.
Table 1 summarizes how FDA believes the risks to health identified
in section V can be mitigated by the proposed special controls.
Table 1--Risks to Health and Mitigation Measures for Rigid Pedicle Screw Systems
----------------------------------------------------------------------------------------------------------------
Identified risks to health Mitigation method
----------------------------------------------------------------------------------------------------------------
Device Failure.............................. Design characteristics.
Non-clinical performance testing.
Labeling.
Failure of Bone Implant Interface........... Design characteristics.
Biocompatibility.
Non-clinical performance testing.
Labeling.
Tissue Injury............................... Labeling.
Adverse Tissue Reaction..................... Design characteristics.
Biocompatibility.
Sterility.
Labeling.
Device Malposition.......................... Labeling.
Pseudoarthrosis............................. Non-clinical performance testing.
Biocompatibility.
Labeling.
----------------------------------------------------------------------------------------------------------------
In addition, under 21 CFR 801.109, the sale, distribution and use
of rigid pedicle screw systems are restricted to prescription use.
Prescription-use restrictions are a type of general control under
section 513(a)(1)(A)(i) of the FD&C Act. Under Sec. 807.81, the device
would continue to be subject to 510(k) notification requirements.
While the 2013 Panel recommended that training be a special
control, we believe that the general control of prescription use is an
adequate substitute. Furthermore, these devices are for prescription
use only, which makes adequate surgeon training implicit.
IX. Dates New Requirements Apply
In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA be filed with the Agency for DSSs that are
preamendments class III devices within 90 days after issuance of any
final order based on this proposal. In addition, in accordance with
section 513(e) of the FD&C Act, FDA is proposing to require that a PMA
be filed with the Agency for DSSs that will be reclassified from class
II to class III. An applicant whose device was legally in commercial
distribution before May 28, 1976, or whose device has been found to be
substantially equivalent to such a device, will be permitted to
continue marketing such class III device during FDA's review of the
PMA, provided that the PMA is timely filed. FDA intends to review any
PMA for the device within 180 days of the date of filing. FDA cautions
that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not
enter into an agreement to extend the review period for a PMA beyond
180 days unless the Agency finds that ``the continued availability of
the device is necessary for the public health.''
Under the FD&C Act, preamendments class III DSSs currently in
distribution for which no PMA is submitted within 90 days of a final
order calling for DSS, or for which a denial is rendered on its filed
PMA, will be considered adulterated under section 501(f)(1) of the FD&C
Act. Nonetheless, for reasons discussed below, FDA does not intend to
ensure compliance with the 90-day
[[Page 67112]]
deadline for PMA submissions, for those manufacturers of currently
marketed class III preamendment DSSs (see further discussion in section
XII). Instead, FDA is proposing to consider allowing continued
distribution for manufacturers of currently marketed DSSs who notify
FDA of their intent to file a PMA within 90 days from the issuance of
the final order based on this proposal. The notification of the intent
to file a PMA submission should include a list of all part numbers for
which a manufacturer plans to seek marketing approval through its PMA.
FDA proposes further to allow continued distribution for DSS devices
lawfully distributed for 30 months from the issuance of a final order
requiring the filing of a PMA for such devices. Manufacturers should be
able to collect additional scientific evidence, to the extent any is
necessary, and prepare PMA submissions, in this time. No new devices
will be allowed into interstate commerce without approval of a PMA. We
request comment on whether it is appropriate to allow continued
distribution and, if so, whether the 30 month period proposed is
reasonable.
FDA intends that under Sec. 812.2(d), the publication in the
Federal Register of any final order based on this proposal will include
a statement that, as of the date on which a PMA is required to be
filed, the exemptions from the requirements of the IDE regulations for
preamendments class III devices in Sec. 812.2(c)(1) and (c)(2) will
cease to apply to any device that is: (1) Not legally on the market on
or before that date or (2) legally on the market on or before that date
but for which a PMA is not filed by that date, or for which PMA
approval has been denied or withdrawn.
If a PMA for a class III device is not filed with FDA within 90
days after the date of issuance of any final order requiring premarket
approval for the device, the device would be deemed adulterated under
section 501(f) of the FD&C Act. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA for review and approval. An approved IDE is
required to be in effect before an investigation of the device may be
initiated or continued under Sec. 812.30. FDA usually recommends that
IDE applications be submitted to FDA at least 30 days before the end of
the 90-day period after the issuance of the final order to avoid
interrupting any ongoing investigations.
However, FDA does not intend to enforce compliance with IDE and PMA
requirements for manufacturers of DSSs who notify FDA of their intent
to file a PMA for such devices within 90 days and file a PMA within 30
months after the date of issuance of any final order requiring
premarket approval for these devices. As stated previously in Section
I.B, because DSSs are currently cleared in either one of two
classifications--class II or class III--if the proposal to require a
PMA is finalized, two different requirements would exist for submission
of a PMA for the same device type (90 days and 30 months,
respectively). Similarly, if the proposal to require a PMA is
finalized, two different requirements would exist for an approved IDE
to be in effect. The Agency believes that all DSS manufacturers should
be provided the same amount of time to comply with the IDE
requirements. Therefore, to avoid an imbalance in IDE requirements for
the same device type, we propose that an approved IDE need not be in
effect until 30 months after the date of issuance of any final order
requiring premarket approval for DSSs. FDA recommends that
manufacturers file a pre-submission to discuss data requirements that
may be necessary to support their individual PMA submission.
Unlike DSSs, rigid pedicle screw systems, when intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
DDD and spondylolisthesis (other than either severe spondylolisthesis
(grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with
objective evidence of neurologic impairment) can currently be marketed
after receiving clearance of a 510(k) submission. Because FDA is
proposing to reclassify these devices as class II requiring clearance
of a 510(k) submission, this order, if finalized, will not impose any
new requirements on rigid pedicle screw systems when intended for these
uses.
X. Device Subject to the Proposal to Require a PMA--DSSs (Proposed
Sec. 888.3070(a)(2))
A. Identification
DSSs are a subset of the pedicle screw spinal systems regulated
under Sec. 888.3070. These systems are defined as systems that contain
one or more of the following features (including but not limited to):
Non-uniform or non-metallic longitudinal elements, features that allow
more motion or flexibility compared to rigid systems, or features that
do not provide the system immediate rigid fixation. DSSs encompass a
large variety of designs and may perform differently as compared to
rigid pedicle screw systems.
B. Summary of Data
As described and summarized in section X.C, FDA concludes that
there is very limited valid scientific evidence available for DSSs when
used as an adjunct to fusion in the treatment of any spinal condition.
Because of the limited data available, FDA believes that safety and
effectiveness have not been established, the risks to health cannot be
fully characterized, special controls cannot be developed, and the
benefits of DSSs cannot be evaluated. The 2013 Panel agreed that the
risks appeared similar to those identified for rigid pedicle screw
systems; however, few data exist to confirm this. The 2013 Panel
recommended that DSSs should remain in class III (subject to premarket
approval application) because insufficient information currently exists
to determine that general controls are sufficient to provide reasonable
assurance of its safety and effectiveness or that application of
special controls would provide such assurance.
C. Risks to Health
As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that DSSs have
an approved PMA and (2) the benefits to the public from the use of
DSSs.
These findings are based on the reports and recommendations of the
2013 Panel for the classification of these devices and any additional
information that FDA has obtained.
Very limited data currently exist regarding the safety and
effectiveness of DSSs when used as an adjunct to fusion in the
treatment of any of the following indications for use: DDD;
spondylolisthesis; degenerative spondylolisthesis with objective
evidence of neurologic impairment; fracture; dislocation; scoliosis;
kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
FDA's presentation to the 2013 Panel included a summary of the
available safety and effectiveness information for DSSs for treatment
of the above described uses, including identification of the limited
literature and adverse event reports from the MAUDE database (Ref. 1).
The limited information from the available published literature, as
well as confounding factors (e.g., lack of identification of the
indications for use, data from devices that are not legally marketed in
the United States), did not
[[Page 67113]]
permit any meaningful conclusions to be drawn. The MAUDE search
described in section 7.4 of FDA's presentation to the 2013 Panel
suggests a potentially higher rate of incidence of serious adverse
events (e.g., device breakage, pain, and reoperation) compared to rigid
pedicle screw systems; however, the overall number of adverse event
reports are very low, due to the limited use and distribution of these
devices. (Ref. 1, FDA Executive Summary, pages 31-33). Given the lack
of data available for these devices, FDA believes that the safety and
effectiveness profile for DSSs is not well established, the risks to
health are not fully characterized for this device subtype, and special
controls cannot be developed at this time to mitigate the risks to
health. The 2013 Panel agreed that the DSSs risks appeared similar to
those listed for rigid pedicle screw systems; however, few data exist
to confirm the risk profile for these devices. The 2013 Panel
recommended that DSSs should remain in class III (subject to premarket
approval application) because insufficient information currently exists
to determine that general controls are sufficient to provide reasonable
assurance of its safety and effectiveness or that application of
special controls would provide such assurance.
Because the benefits of DSSs for the above described uses are
unknown, it is not currently possible to truly estimate the direct
effect of the DSSs on patient outcomes. However, claims for the devices
state the devices have the potential to benefit the public in the
following ways: Reduced risk for screw fracture and reduced stress-
shielding at the treated level.
XI. PMA Requirements
A PMA for a DSS, when used as an adjunct to fusion in the treatment
of any spinal condition, must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks to health, as well as a discussion of
the effectiveness of the device for which premarket approval is sought.
In addition, a PMA must include all data and information on: (1) Any
risks known, or that should be reasonably known, to the applicant that
have not been identified in this document; (2) the effectiveness of the
device that is the subject of the application; and (3) full reports of
all preclinical and clinical information from investigations on the
safety and effectiveness of the device for which premarket approval is
sought. A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec. 860.7(c)(1)). Valid scientific evidence is
``evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use . . . Isolated case reports, random
experience, reports lacking sufficient details to permit scientific
evaluation, and unsubstantiated opinions are not regarded as valid
scientific evidence to show safety or effectiveness.'' (See Sec.
860.7(c)(2).)
XII. Implementation Strategy for Currently Marketed DSSs
For clarification, if this proposed order is finalized, and under
section 501(f)(2)(B), PMAs for currently marketed DSSs are required to
be filed on or before 90 days after the date of issuance of a final
order in the Federal Register. However, for currently marketed DSSs,
FDA does not intend to ensure compliance with this 90-day deadline
until 30 months after that deadline (i.e., 33 months after the issuance
of the final order) for class III preamendments DSSs, as long as notice
of intent to file a PMA is submitted within 90 days of issuance of the
final order. The notification of the intent to file a PMA submission
must include a list of all part numbers for which a manufacturer plans
to seek marketing approval through its PMA. Manufacturers should be
able to collect additional scientific evidence, to the extent any is
necessary, and prepare PMA submissions, in this time. No new devices
will be allowed into interstate commerce without approval of a PMA.
In conducting any clinical studies, DSSs may be distributed for
investigational use if the requirements of the IDE regulations (part
812) are met. There will be neither extended period for filing an IDE
nor exemption from IDE requirements, and studies may not be initiated
without appropriate IDE approvals, where necessary.
XIII. Opportunity To Request a Change in Classification
Before requiring the filing of a PMA for a device, FDA is required
by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for
interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the FD&C Act.
A request for a change in the classification of DSSs, when used as
an adjunct to fusion in the treatment of any spinal condition, is to be
in the form of a reclassification petition containing the information
required by Sec. 860.123, including new information relevant to the
classification of the device.
XIV. Codification of Orders
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices and section
515(b) of the FD&C Act provided for FDA to issue regulations to require
approval of an application for PMA for preamendments devices or devices
found to be substantially equivalent to preamendments devices. Because
sections 513(e) and 515(b) of the FD&C Act, as amended by FDASIA,
require FDA to issue final orders rather than regulations, FDA will
continue to codify reclassifications and requirements for approval of a
PMA, resulting from changes issued in final orders, in the CFR.
Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as
amended by FDASIA, in this proposed order, we are proposing to revoke
the requirements in Sec. 888.3070 related to the classification of
rigid pedicle screw systems when used for immobilization and
stabilization as an adjunct to fusion in the treatment of DDD and
spondylolisthesis (other than either severe spondylolisthesis (grades 3
and 4) at L5-S1 or degenerative spondylolisthesis with objective
evidence of neurologic impairment) as class III devices and to codify
the reclassification of rigid pedicle screw systems when used for
immobilization and stabilization as an adjunct to fusion in the
treatment of DDD and spondylolisthesis (other than either severe
spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment)
into class II.
XV. Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
[[Page 67114]]
XVI. Paperwork Reduction Act of 1995
This proposed order refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231. The collections of information in part
807, subpart E, have been approved under OMB control number 0910-0120.
The effect of this order, if finalized, is to shift DSSs devices
from the 510(k) premarket notification process to the PMA process. To
account for this change, FDA intends to transfer some of the burden
from OMB control number 0910-0120, which is the control number for the
510(k) premarket notification process, to OMB control number 0910-0231,
which is the control number for the PMA process. FDA estimates that it
will receive 16 new PMAs for DSS as a result of this order, if
finalized. Based on FDA's most recent estimates, this will result in
16,601 hours burden increase to OMB control number 0910-0231. FDA also
estimates that there will be 16 fewer 510(k) submissions as a result of
this order, if finalized. Based on FDA's most recent estimates, this
will result in 2,179 hours decrease to OMB control number 0910-0120.
Therefore, on net, FDA expects a burden hour increase of 14,422 hours
due to this proposed regulatory change.
The collections of information in part 812 have been approved under
OMB control number 0910-0078.
XVII. Proposed Effective Date
FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.
XVIII. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
XIX. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
1. FDA, the May 22, 2013 Panel transcript and other meeting
materials (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm352525.htm).
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 888 be amended as follows:
PART 888--ORTHOPEDIC DEVICES
0
1. The authority citation for 21 CFR part 888 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 888.3070 is amended by revising paragraphs (a) and (b)(2),
adding paragraph (b)(3), and revising paragrpah (c) to read as follows:
Sec. 888.3070 Pedicle screw spinal system.
(a) Identification. (1) Rigid pedicle screw systems are
prescription devices comprised of multiple components, made from a
variety of materials that allow the surgeon to build an implant system
to fit the patient's anatomical and physiological requirements. Such a
spinal implant assembly consists of a combination of hooks, screws,
longitudinal members (e.g., plates, rods, plate/rod combinations),
transverse or cross connectors, and interconnection mechanisms (e.g.,
rod-to-rod connectors, offset connectors). These systems are intended
for immediate rigid fixation as an adjunct to fusion.
(2) Dynamic stabilization systems are defined as systems that
contain one or more non-uniform and/or non-metallic longitudinal
elements (e.g., polymer cords, moveable screw heads, springs) that
allow more motion or flexibility (e.g., bending, rotation, translation)
compared to rigid pedicle screw systems and do not provide immediate
rigid fixation to the spinal column as an adjunct fusion.
(b) * * *
(2) Class II (special controls), when a rigid pedicle screw system
is intended to provide immobilization and stabilization of spinal
segments in the thoracic, lumbar, and sacral spine as an adjunct to
fusion in the treatment of degenerative disc disease and
spondylolisthesis other than either severe spondylolisthesis (grades 3
and 4) at L5-S1 or degenerative spondylolisthesis with objective
evidence of neurologic impairment. These pedicle screw spinal systems
must comply with the following special controls:
(i) The design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the
mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and
sterility of, or the ability to clean and sterilize, the device
components and device-specific instruments.
(v) Labeling must bear all information required for the safe and
effective use of the device, specifically including the following:
(A) A clear description of the technological features of the device
including identification of device materials and the principles of
device operation;
(B) Intended use and indications for use including levels of
fixation;
(C) Identification of magnetic resonance compatibility status;
(D) Cleaning and sterilization instructions for devices and
instruments that are provided nonsterile to the end user; and
(E) Detailed instructions of each surgical step, including device
removal.
(3) Class III (premarket approval) when a dynamic stabilization
system is intended to provide stabilization of spinal segments in the
thoracic, lumbar, and sacral spine as an adjunct to fusion for any
indication.
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before [DATE 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER] for any
dynamic stabilization system that was in commercial distribution before
May 28, 1976, or that has, on or before [DATE 90 DAYS AFTER DATE OF
PUBLICATION OF A FUTURE FINAL ORDER IN THE FEDERAL REGISTER] been found
to be substantially equivalent to a pedicle
[[Page 67115]]
screw spinal system that was in commercial distribution before May 28,
1976. Any other dynamic stabilization system shall have an approved PMA
or a declared completed PDP in effect before being placed in commercial
distribution.
Dated: November 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26726 Filed 11-10-14; 8:45 am]
BILLING CODE 4164-01-P