[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Rules and Regulations]
[Pages 19626-19628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2017-N-6216]
General Hospital and Personal Use Devices; Reclassification of
Sharps Needle Destruction Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify the needle destruction device,
renaming the device to ``sharps needle destruction device,'' a
postamendments class III device (regulated under product code MTV),
into class II (special controls), subject to premarket notification.
FDA is also identifying the special controls that the Agency believes
are necessary to provide a reasonable assurance of safety and
effectiveness of the device. FDA is finalizing this reclassification on
its own initiative based on new information. The Agency is classifying
the device into class II (special controls) to provide a reasonable
assurance of safety and effectiveness of the device. This order
reclassifies these types of devices from class III to class II and will
reduce regulatory burdens on industry because these types of devices
will no longer be required to submit a premarket approval application
(PMA), but can instead submit a less burdensome premarket notification
(510(k)) before marketing their device.
DATES: This order is effective June 4, 2018.
FOR FURTHER INFORMATION CONTACT: Christopher K. Dugard, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240-
402-6031, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
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).
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)(1) 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 postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or class II under section 513(f)(3). Section 513(f)(3) of the
FD&C Act provides that FDA acting by order can reclassify the device
into class I or class II on its own initiative, or in response to a
petition from the manufacturer or importer of the device. To change the
classification of the device, the proposed new class must have
sufficient regulatory controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use.
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 regulatory authority (see Bell
[[Page 19627]]
v. Goddard, 366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA,
762 F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in
``medical science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir.
1970)). Whether data before the Agency are old or new, the ``new
information'' to support reclassification under 513(f)(3) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766
F.2d 592 (D.C. Cir.1985), cert. denied, 474 U.S. 1062 (1986).)
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
520(h)(4) of the FD&C Act provides that FDA may use, for
reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This includes information from
clinical and preclinical tests or studies that demonstrate the safety
or effectiveness of the device, but does not include descriptions of
methods of manufacture or product composition and other trade secrets.
Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the 510(k) premarket notification requirements, if the
Agency determines that premarket notification is not necessary to
reasonably assure the safety and effectiveness of the device.
On November 7, 2017, FDA published an order in the Federal Register
to reclassify the device (82 FR 51585) (the ``proposed order''). The
period for public comment on the proposed order closed on January 8,
2018. FDA received and has considered two comments on the proposed
order, as discussed in section II.
II. Comments on the Proposed Order and FDA Response
A. Introduction
We received two comments on the proposed order and both comments
supported the proposed reclassification. The comments were received
from a consumer and a healthcare professional in the drug industry.
We describe and respond to the comments in section B of this
section. The order of response to the commenters is purely for
organizational purposes and does not signify the comment's value or
importance nor the order in which comments were received.
B. Description of Comments and FDA Response
(Comment 1) One commenter discussed the experience of witnessing
sharps disposal and was supportive of safe and cost-effective options
for sharps disposal due to the potential injury to sanitation works or
patients/users with improper disposal of sharps. The commenter was
generally supportive of FDA's proposed reclassification. Additionally,
the commenter stated that PMA requirements increase the price of these
devices and that reclassification increases affordability of the sharps
needle destruction devices, while ensuring safety.
(Response 1) FDA agrees with this comment. The Agency believes that
reclassification of the sharps needle destruction device will reduce
the regulatory burden on manufacturers, which could increase patient
access to these devices and potentially reduce accidental needle
sticks, while still providing reasonable assurance of safety and
effectiveness. Additionally, FDA believes the special controls mitigate
workplace hazards associated with sharps needle destruction and ensures
proper use of the device.
(Comment 2) One commenter noted that while a PMA for these devices
will no longer be required, FDA will still require premarket
notification under section 510(k) of the FD&C Act. The commenter stated
that in addition to 510(k) requirements, a prescription use
restriction, and labeling, the identified special controls will provide
reasonable assurance of device safety and effectiveness. The commenter
noted that PMAs delay the access of these devices to patients. The
commenter concluded that this reclassification may factor in positive
outcomes for patient access and safety.
(Response 2) FDA agrees with this comment. The Agency believes that
the special controls required in this final order provide a reasonable
assurance of safety and effectiveness for these devices. FDA believes
it has identified the risks to health (see section V of the proposed
order) and that the measures described in this final order will be
effective in mitigating the identified probable risks to health.
Additionally, by reclassifying these types of devices from class III to
class II, this will reduce regulatory burdens on industry because these
types of devices will no longer be required to submit a PMA, but can
instead submit a less burdensome premarket notification (510(k)) before
marketing their device.
III. The Final Order
FDA is adopting its findings under section 513(f)(3) of the FD&C
Act, as published in the preamble to the proposed order. FDA is issuing
this final order to reclassify needle destruction devices from class
III to class II, rename them sharps needle destruction devices, and
establish special controls by revising 21 CFR part 880. In this final
order, the Agency has identified the special controls under section
513(a)(1)(B) of the FD&C Act that, together with general controls,
provide a reasonable assurance of the safety and effectiveness for
sharps needle destruction devices.
FDA may exempt a class II device from the premarket notification
requirements under section 510(k) of the FD&C Act under section 510(m)
of the FD&C Act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of sharps needle destruction devices, and therefore, this
device type is not exempt from premarket notification requirements.
The device is assigned the generic name sharps needle destruction
device, and it is identified as a prescription device that is intended
to destroy needles or sharps used for medical purposes by incineration
or mechanical means.
Under this final order, the sharps needle destruction device is a
prescription use device under Sec. 801.109 (21 CFR 801.109).
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of Sec. 801.109 are met (referring to 21 U.S.C. 352(f)(1)).
Under 21 CFR 807.81, the device would continue to be subject to 510(k)
requirements.
IV. Analysis of Environmental Impact
We have determined under 21 CFR 25.34(b) 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 19628]]
V. Paperwork Reduction Act of 1995
This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. 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 part 807, subpart E have been approved under OMB control
number 0910-0120 and the collections of information under 21 CFR part
801 have been approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for part 880 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 880.6210 to subpart G to read as follows:
Sec. 880.6210 Sharps needle destruction device.
(a) Identification. A sharps needle destruction device is a
prescription device that is intended to destroy needles or sharps used
for medical purposes by incineration or mechanical means.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Performance testing must demonstrate the following during
operation of the device:
(i) The device safely contains or ventilates aerosols or fumes from
device operation.
(ii) Excessive heat or sparks are not generated that may injure
users or patients.
(iii) Simulated use testing must demonstrate sharps and/or needles
are completely destroyed using a range of types and sizes of sharps
sufficient to represent actual use.
(iv) Simulated use testing must demonstrate that the device is
physically stable on the surface for which it is intended to be mounted
to ensure the risk of harm to the patient/user as a result of the
device falling is minimized.
(2) Validation of cleaning and disinfection instructions must
demonstrate that the device can be safely and effectively reprocessed
after use per the recommended cleaning and disinfection protocol in the
instructions for use.
(3) Analysis and/or testing must validate electromagnetic
compatibility and electrical safety, including the safety of any
battery used in the device, under conditions which are consistent with
the intended environment of device use.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Labeling must include:
(i) A clear description of the device and its technological
features;
(ii) How the device is to be used, including validated cleaning and
disinfection instructions;
(iii) Relevant precautions and warnings based on performance and
in-use testing to ensure proper use of the device; and
(iv) Instructions to install device in adequately ventilated area
and stable area.
Dated: April 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09434 Filed 5-3-18; 8:45 am]
BILLING CODE 4164-01-P