[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Proposed Rules]
[Pages 41023-41026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17731]
[[Page 41023]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 876, 878, and 886
[Docket No. FDA-2018-N-3066]
Medical Devices; Classification of Accessories Distinct From
Other Devices; Proposed List of Accessories Suitable for Class I;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; request for comments.
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SUMMARY: As required by the FDA Reauthorization Act of 2017 (FDARA),
the Food and Drug Administration (FDA or Agency) has identified a list
of accessories for which the Agency believes general controls alone are
sufficient to provide reasonable assurance of safety and effectiveness,
so the accessories could be in class I. FDA is publishing this document
proposing to classify these accessories into class I and distinct from
other devices, as well as seek public comment in accordance with
procedures established by FDARA. This document does not represent FDA's
final determination with respect to the proposed accessories listed in
this document.
DATES: Submit either electronic or written comments on the document by
October 16, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 16, 2018 The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3066 for ``Medical Devices; Classification of Accessories
Distinct from Other Devices; Proposed List of Accessories Suitable for
Class I; Request for Comments.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5454, Silver Spring, MD 20993-0002, 301-
796-5678.
SUPPLEMENTARY INFORMATION:
I. Background
On August 18, 2017, FDARA was signed into law (Pub. L. 115-52).
Section 707 of FDARA amended section 513(f) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and, among other amendments, created a
process for FDA to propose a list of accessories suitable for distinct
classification into class I (see section 513(f)(6)(D)(i) of the FD&C
Act (21 U.S.C. 360c(f)(6)(D)(i))). Section 707 of FDARA mandated that
FDA make the first such proposal within a year of enactment of FDARA,
and FDA is publishing this document in accordance with this statutory
mandate.
Section 201(h) of the FD&C Act defines ``device'' to include, among
other articles, an ``accessory'' (see 21 U.S.C. 321(h)). As such, all
articles that meet the definition of ``device'', including accessories,
are regulated under the FD&C Act. Based on sections 201(h) and
513(f)(6) of the FD&C Act, we have described our current thinking on
which devices we would generally consider to be accessories in the
guidance document, ``Medical Device Accessories--Describing Accessories
and Classification Pathways,'' available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672
(``Accessories Guidance''). That
[[Page 41024]]
guidance defines an accessory as a ``finished device that is intended
to support, supplement, and/or augment the performance of one or more
parent devices.''
Section 513 of the FD&C Act defines three classes of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three classes of
devices are class I (general controls), class II (special controls),
and class III (premarket approval). Some accessories may be granted
marketing authorization as part of a submission for another device with
which they are intended to be used and in class II or III that, if
considered distinctly from another device (such as the parent device),
may be suitable for classification into class I if general controls
alone are sufficient to provide a reasonable assurance of safety and
effectiveness of the accessory.
Section 513(h)(1) defines general controls as the controls
authorized by or under sections 501, 502, 510, 516, 518, 519, and 520
of the FD&C Act. These controls include, but are not limited to,
provisions related to adulteration and misbranding, registration and
listing, records and reports on devices, and good manufacturing
practices. The regulations for good manufacturing practices are under
21 CFR part 820, the Quality System regulation. Subject to the
exceptions identified in Sec. 820.30(a)(2) (21 CFR 820.30(a)(2)) for
specific devices and those automated with computer software, design
controls under Sec. 820.30 do not generally apply to a class I device.
This document represents FDA's compliance with FDARA's requirement
to identify the first list of accessories suitable for distinct
classification into class I. As required by FDARA, we are providing you
with the opportunity to provide comment. Once the comment period ends,
we will consider the comments and publish in the Federal Register a
final action classifying such suitable accessories into class I.
II. Factors for Consideration
The classification of each accessory will be based on the risks of
the accessory when used as intended and the level of regulatory
controls necessary to provide a reasonable assurance of safety and
effectiveness of the accessory, notwithstanding the classification of
any other device with which such accessory is intended to be used (see
section 513(f)(6)(A) of the FD&C Act).
In general, we considered an accessory to be eligible for
classification into class I distinct from another device if the
accessory: (1) Is not for use in supporting or sustaining human life,
or of substantial importance in preventing impairment to human health;
(2) does not represent a potential unreasonable risk of illness or
injury; and (3) general controls alone would be sufficient to provide a
reasonable assurance of safety and effectiveness of the accessory.
Note that by regulation, design controls apply to class I devices
only if the devices are automated with computer software or are listed
under Sec. 820.30(a)(2)(ii). Thus, if an accessory is not automated
with computer software but would require design controls to provide
reasonable assurance of safety and effectiveness, we did not consider
it eligible for classification through the final action based on this
document.
You may wish to propose additional accessories as suitable for
distinct classification into class I using the factors described above
where the accessories are otherwise eligible for classification under
section 513(f)(6)(D)(i) of the FD&C Act. Should you wish to propose
additional accessories, your comment should briefly explain why you
think general controls alone will provide reasonable assurance of
safety and effectiveness. Conversely, should you disagree with any of
the proposed accessories for class I, your comments should briefly
explain why additional regulatory controls, such as premarket review
through a 510(k) submission or premarket approval (PMA), are necessary
to provide reasonable assurance of safety and effectiveness.
III. Policy Clarification for Classification of Certain Accessories
Used in Orthopedic Surgery
Certain manual orthopedic instruments that are for use with other
devices in orthopedic surgery meet FDA's definition of an accessory
described in the Accessories Guidance. Accordingly, we are clarifying
our intended regulatory approach for certain accessories used in
orthopedic surgery to distinguish which accessories may be candidates
for classification per section 513(f)(6)(D)(i) of the FD&C Act.
Instruments for use in orthopedic surgery vary widely from general
manual surgical instruments used to manipulate tissue to more complex
accessories specifically designed for use with a parent device/system.
Orthopedic manual surgical instruments are classified in Sec. 888.4540
(21 CFR 888.4540), and many ``general use'' instruments fall within
this classification. This regulation pertains to ``nonpowered hand-held
device[s] intended for medical purposes to manipulate tissue, or for
use with other devices in orthopedic surgery.'' These devices are class
I, subject to general controls, and exempt from premarket notification
procedures, subject to the limitations of exemptions in 21 CFR 888.9.
This classification was based upon recommendations provided to FDA by
the Orthopedic Device Classification Panel (the Panel) in October 1977
regarding classification of medical devices in commercial distribution
before May 28, 1976. The Panel identified the following risks to health
for this device type: ``Tissue damage and adverse tissue reaction:
Inadequate mechanical properties, such as lack of material strength of
the device, may result in device fracture and possible tissue damage
and, if fragments of the fractured device remain in the tissue, an
adverse tissue reaction may result'' (47 FR 29052).
FDA agreed that class I was appropriate because general controls
alone were sufficient to mitigate the risk of tissue damage and adverse
tissue reaction associated with inadequate mechanical properties and
provide a reasonable assurance of the safety and effectiveness of these
devices. Over time, manufacturers have developed and sought to market
orthopedic instrumentation with designs unique to a device system, and
these types of instruments may present new or different risks compared
to inadequate mechanical properties. For example, certain device-
specific instruments are accessories and require precise technical
specifications or design characteristics to function as intended to
support, supplement or augment the parent device, and if not designed
appropriately, could cause implant malpositioning or migration.
Accordingly, FDA considers design controls (see Sec. 820.30) to be an
important element in the regulation of device-specific accessories,
among other regulatory controls, to ensure appropriate compatibility
between the accessory and the parent device. In contrast, class I
orthopedic manual surgical instruments do not require such controls.
Instruments that are ``device-specific,'' or designed for use with
a specific parent device/system and thus are accessories, have
historically been reviewed in the same premarket submission as the
parent device. In an effort to ensure a common understanding as to
which orthopedic accessories fall under the existing class I regulation
(Sec. 888.4540), and which devices do not and, therefore, may be
candidates for classification under section 513(f)(6)(D)(i) of the FD&C
Act,
[[Page 41025]]
we propose the following definition: A device-specific orthopedic
instrument is considered to be an accessory designed specifically for
appropriate implantation or placement of the parent device, based upon
unique dimensions, geometry, and/or deployment. In these cases, design
specifications are critical to the proper use of the accessory in
supporting, supplementing, and/or augmenting the performance of the
parent device and/or a specific system. This excludes general use
orthopedic instruments that are provided as a part of a system.
It is often necessary for orthopedic instruments to be described in
a premarket submission (e.g., 510(k), PMA) to evaluate that the parent
device functions as intended. Such orthopedic instruments may be
appropriately classified in an existing class I regulation (Sec.
888.4540) if they do not meet the definition of a device-specific
orthopedic accessory above and their risk profile and necessary
regulatory controls are commensurate with that of orthopedic manual
surgical instruments. If they do meet the definition of a device-
specific orthopedic accessory above, then such orthopedic accessories
may still be eligible for classification under section 513(f)(6)(D)(ii)
of the FD&C Act.
We welcome comments to help identify accessories in other product
areas where the classification of the accessory relative to the parent
device may be unclear and would benefit from this type of policy
clarification.
IV. Proposed List of Accessories That May Be Suitable for Distinct
Classification Into Class I
We are proposing the following accessories, which have been granted
marketing authorization as part of a premarket submission (i.e.,
510(k), De Novo classification request, or PMA) for another device with
which they are intended to be used, as suitable for distinct
classification into class I (see Table 1). When we publish the final
list of accessories based on this list and the factors in section II,
we will consider those accessories classified into class I, distinct
from other devices, through such action.
We would place each of these accessories in 21 CFR part 876, 878,
or 886, as appropriate. Each of these accessories would be class I,
exempt from the premarket notification procedures in 21 CFR part 807,
subject to the applicable limitations of exemption (i.e., 21 CFR 876.9,
878.9, or 886.9). We intend to make conforming changes to existing
classification regulations as appropriate.
Table 1--Proposed Accessories for Classification Into Class I and
Distinct From Other Devices
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Current status of accessory
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Device type Proposed device type
Current classification (existing product identification
regulation (21 CFR) code)
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876.1075...................... Gastroenterology- Accessories used to
urology remove a specimen of
accessories to a tissue for
biopsy microscopic
instrument (FCG). examination by
cutting or
aspiration. This
generic type of
device includes a
syringe for specimen
aspiration and a
biopsy channel
adaptor. This device
does not include
accessories to
biopsy instruments
used in other
medical specialty
areas.
876.3350 and 876.3630......... Penile implant Manual devices
surgical designed to be used
accessories (JCW for surgical
and FHW). procedures
associated with the
implantation of a
penile inflatable
implant or penile
rigidity implant.
This generic type of
device includes the
cylinder sizer,
cylinder insertion
tool, connector
assembly tool,
incision closing
tool, corporeal
dilator, tubing
passer, measurement
tool or tape,
temporary tubing
plug, and hemostat
shod tubing.
876.4620...................... Ureteral stent Accessories that aid
accessories in the insertion of
(FAD). the ureteral stent
that is placed into
the ureter to
provide ureteral
rigidity and allow
the passage of
urine. This generic
type of device
includes the stent
positioner, wire
guide, and pigtail
straightener.
876.5010...................... Biliary stent, Manual devices that
drain, and aid in the
dilator introduction and
accessories connection of
(FGE). biliary stents,
drains, or dilators.
This generic type of
device includes the
guiding catheter,
pushing catheter,
pigtail
straightener, flap
protector, nasal
transfer tube, and
drainage connecting
tube.
876.5090...................... Suprapubic Manual devices that
catheter are used to
accessories facilitate the
(KOB). placement of a
suprapubic catheter.
This generic type of
device includes the
introducer, access
dilator, and peel-
away sheath.
876.5280...................... Implanted Manual devices
mechanical/ designed to be used
hydraulic for surgical
urinary procedures
continence associated with the
device surgical implantation of an
accessories implanted mechanical/
(EZY). hydraulic urinary
continence device.
This generic type of
device includes the
measurement tool or
tape, connector
assembly tool,
temporary tubing
plug, incision
closing tool, tubing
passer, and hemostat
shod tubing.
878.5070...................... Air-handling Supplementary device
apparatus that is intended to
accessory (FYD). be used with an air-
handling apparatus
for a surgical
operating room. This
device provides an
interface between
the components of
the device or can be
used to switch
electrical power.
This generic type of
device includes
fittings, adapters,
couplers, remote
switches, and
footswitches.
No corresponding CFR Section.. Corneal inlay Hand-held device
inserter handle intended to be used
(LQE). as an accessory to a
corneal inlay
inserter. The device
extends the length
of the inlay
inserter to aid in
delivering the inlay
implant.
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V. Paperwork Reduction Act of 1995
This document refers to previously approved collections of
information. These collections of information 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
the following FDA
[[Page 41026]]
regulations and guidance have been approved by OMB as listed in the
following table:
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21 CFR part; guidance; or FDA OMB control
form Topic No.
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807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
``De Novo Classification De Novo classification 0910-0844
Process (Evaluation of process.
Automatic Class III
Designation)''.
800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
``Medical Device Accessories-- Medical Device 0910-0823
Describing Accessories and Accessories.
Classification Pathways for
New Accessory Types''.
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Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17731 Filed 8-16-18; 8:45 am]
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