[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20174-20177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]


Making Permanent Regulatory Flexibilities Provided During the 
COVID-19 Public Health Emergency by Exempting Certain Medical Devices 
From Premarket Notification Requirements; Withdrawal of Proposed 
Exemptions

AGENCY: Department of Health and Human Services (HHS), Food and Drug 
Administration (FDA).

ACTION: Notice of withdrawal.

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SUMMARY: The Department of Health and Human Services (HHS or ``The 
Department'') issued a Notice in the Federal Register of January 15, 
2021, that, among other things, proposed to exempt 83 class II devices 
and 1 unclassified device from premarket notification. This Notice 
announces HHS's and the Food and Drug Administration's (FDA or ``the 
Agency'') withdrawal of the proposed exemptions for the 83 class II 
devices and 1 unclassified device. The comment period for the proposed 
class II and unclassified device exemptions closed on March 15, 2021. 
HHS and FDA are withdrawing the proposed exemptions after reviewing the 
Notice, its comments, inquiries to FDA, and other relevant information, 
and determining that the proposed exemptions and bases for them are 
flawed.

DATES: The proposed exemptions of 83 class II devices and 1 
unclassified device, published on January 15, 2021 (86 FR 4088), are 
withdrawn as of April 16, 2021.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1660, Silver Spring, MD 20993, 301-796-
6380, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (``1976 amendments'') (Pub. L. 94-
295), and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), 
devices are classified into class I (``general controls'') if there is 
information showing that the general controls of the FD&C Act are 
sufficient to assure safety and effectiveness; into class II (``special 
controls''), if general controls, by themselves, are insufficient to 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide such 
assurance; and into class III (premarket approval), if there is 
insufficient information to support classifying a device into class I 
or class II and the device is a life sustaining or life supporting 
device, or is for a use which is of substantial importance in 
preventing impairment of human health, or presents a potential 
unreasonable risk of illness or injury.
    Most generic device types that were on the market before the date 
of the 1976 amendments (May 28, 1976) (generally referred to as 
``preamendments devices'') have been classified by FDA under the 
procedures set forth in section 513(c) and (d) of the FD&C Act through 
the issuance of classification regulations into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as 
``postamendments devices''), are generally classified through the 
premarket notification process under section 510(k) of the FD&C Act (21 
U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing 
regulations in 21 CFR part 807 require persons who intend to market a 
new device to submit a premarket notification (510(k)) containing 
information that allows FDA to determine whether the new device is 
``substantially equivalent'' within the meaning of section 513(i) of 
the FD&C Act to a legally marketed device that does not require 
premarket approval.
    Section 510(m)(2) of the FD&C Act allows FDA, on its own initiative 
or in response to an exemption petition, to issue in the Federal 
Register a notice of intent to exempt any type of class II device from 
the requirement to submit a report under section 510(k) of the FD&C 
Act, if the Agency determines that such a report is not necessary to 
assure the safety and effectiveness of the device. Section 510(m)(2) 
further provides that the public may comment on FDA's proposed 
exemptions for 60 days after publication in the Federal Register and 
that FDA shall issue an order setting forth the final determination 
within 120 days.
    In addition, section 510(m)(1)(A) of the FD&C Act requires FDA to, 
within

[[Page 20175]]

90 days after enactment in December 2016 and at least once every 5 
years, publish a list of each type of class II device that FDA 
determines no longer requires a report under section 510(k) to provide 
a reasonable assurance of safety and effectiveness, along with a public 
comment period of at least 60 days. Section 510(m)(3) provides that, 
upon publication of the final list in the Federal Register, each type 
of class II device listed shall be exempt from the requirement for a 
report under section 510(k), and the classification regulation 
applicable to each type of device shall be deemed amended to 
incorporate such exemption. In accordance with these statutory 
requirements, FDA published a notice of proposed class II exemptions in 
the Federal Register on March 14, 2017 (82 FR 13609), and a final list 
of its class II exemptions on July 11, 2017 (82 FR 31976).

II. Criteria for Exemption From Section 510(k) of the FD&C Act

    Section 510(m)(2) of the FD&C Act permits FDA to exempt class II 
devices from the premarket notification requirements of section 510(k), 
where the Agency has determined that such notification is not necessary 
to assure the safety and effectiveness of the device. To make that 
determination, FDA considers a number of factors, which the Agency 
first described in the January 21, 1998, Federal Register notice (63 FR 
3142), and explained in FDA's guidance issued on February 19, 1998, 
entitled ``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (Class II 510(k) 
Exemption Guidance).1 2 As described in those documents, FDA 
generally considers the following factors to determine whether class II 
device types should be exempted from premarket notification: (1) The 
device does not have a significant history of false or misleading 
claims or of risks associated with inherent characteristics of the 
device; (2) characteristics of the device necessary for its safe and 
effective performance are well established; (3) changes in the device 
that could affect safety and effectiveness will either (a) be readily 
detectable by users by visual examination or other means such as 
routine testing, before causing harm, or (b) not materially increase 
the risk of injury, incorrect diagnosis, or ineffective treatment; and 
(4) any changes to the device would not be likely to result in a change 
in the device's classification.
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    \1\ On January 21, 1998, to comply with the requirements of the 
Food and Drug Administration Modernization Act of 1997, FDA 
published a list of class II devices exempt from premarket 
notification. After the 21st Century Cures Act went into effect, in 
compliance with the requirement of section 510(m)(1)(A), FDA 
published a notice of proposed class II device type exemptions in 
the Federal Register on March 14, 2017 (82 FR 13609), and a final 
list of its class II exemptions on July 11, 2017 (82 FR 31976).
    \2\ The guidance for industry and Center for Devices and 
Radiological Health (CDRH) is available at https://www.fda.gov/
files/medical%20devices/published/Procedures-for-Class-II-Device-
Exemptions-from-Premarket-Notification_Guidance-for-Industry-and-
CDRH-Staff-%28PDF-Version%29.pdf.
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    FDA may also consider that, even when exempting devices, these 
devices will still be subject to the limitations on exemptions. After 
considering these factors, FDA determines whether specific device types 
are appropriate for exemption from section 510(k) because a report 
under section 510(k) is not necessary to assure the safety and 
effectiveness of the device. FDA has published several lists of class 
II device types exempted or proposed to be exempted from the premarket 
notification requirements of section 510(k), including on January 21, 
1998 (63 FR 3142), March 14, 2017 (82 FR 13609), and July 11, 2017 (82 
FR 31976). Since enactment of section 510(m) of the FD&C Act, each time 
that FDA has published a list of exemptions, it has reiterated the 
above criteria that it evaluates and has documented the determination 
that a 510(k) submission is not necessary to assure the safety and 
effectiveness of the device.

III. Limitations on Exemptions

    Exemptions to the premarket notification requirements of 510(k) 
apply only to those devices that have existing or reasonably 
foreseeable characteristics of commercially distributed devices within 
that generic type. General limitations to exemptions for class II 
devices are set forth in each of the device classification regulations 
(Sec. Sec.  862.9 through 892.9 (21 CFR 862.9 through 892.9)). Thus, a 
manufacturer of an exempted device is still required to submit a 
premarket notification before introducing a device or delivering it for 
introduction into commercial distribution when the device meets any of 
the conditions described in Sec. Sec.  862.9 through 892.9.
    In addition, FDA may also partially limit an exemption within a 
listed device type, taking into account the factors described in the 
Class II 510(k) Exemption Guidance. For example, although FDA has 
granted an exemption under 510(m)(2) to certain optical position/
movement recording systems, it limits that exemption to devices for 
prescription use only (85 FR 44186, July 22, 2020). In those 
situations, FDA determined that premarket notification is necessary to 
provide a reasonable assurance of safety and effectiveness for a subset 
of those devices of the listed device type.
    The exemption from the requirement of premarket notification does 
not mean that the device is exempt from any other statutory or 
regulatory requirements, unless such exemption is explicitly provided 
by order or regulation. FDA's determination that premarket notification 
is unnecessary to provide a reasonable assurance of safety and 
effectiveness for certain devices is based, in part, on the assurance 
of safety and effectiveness that other regulatory controls, such as 
current good manufacturing practice requirements, provide.

IV. FDA's Enforcement Policy During the Public Health Emergency

    FDA has issued guidance documents related to the Coronavirus 
Disease 2019 (COVID-19) public health emergency (COVID-19 PHE), some of 
which set forth enforcement policies intended to help expand the 
availability of certain devices by providing regulatory flexibility for 
products that have already submitted premarket notification.\3\ For 
each such enforcement policy, FDA has noted that it does not intend to 
object to certain modifications to these devices or their indications 
of use. For all of the guidance documents related to devices, FDA 
specifically limited the policies to the duration of the COVID-19 PHE.
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    \3\ FDA's guidances related to the COVID-19 PHE are available 
at: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders.
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    In one such guidance, FDA's ``Enforcement Policy for Ventilators 
and Accessories and Other Respiratory Devices During the Coronavirus 
Disease 2019 (COVID-19) Public Health Emergency'' (Ventilator 
Guidance), FDA stated its intention not to object to limited 
modifications to the indications, claims, functionality, or to the 
hardware, software, or materials of class II FDA-cleared devices used 
to support patients with respiratory failure or respiratory 
insufficiency, without prior submission of a premarket notification 
under section 510(k), where the modification will not create an undue 
risk in light of the COVID-19 PHE.\4\ In addition, FDA's Ventilator 
Guidance noted that FDA does not intend to object to changes in the 
indicated shelf life and duration of use of these products for treating 
individual patients, without

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prior submission of a premarket notification under section 510(k) of 
the FD&C Act and 21 CFR 807.81, where the change does not create an 
undue risk in light of the COVID-19 PHE. FDA's Ventilator Guidance 
provided examples of circumstances where FDA currently believes these 
types of modifications would not create such an undue risk.
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    \4\ The policies set forth in the Ventilator Guidance apply to 
ventilators with the product codes CBK, MNT, NOU, NQY, MNS, ONZ, 
BTL, BSZ, BZD, NFB, NHJ, NHK, and QAV.
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    These enforcement policies are limited in scope and duration, and 
they communicate FDA's nonbinding views about how it should allocate 
its enforcement resources based on current facts and circumstances. 
Such policies do not alter the legal obligation to comply with the 
relevant requirements and do not preclude the Agency from taking action 
to enforce those requirements where appropriate. These particular 
enforcement policies were issued in response to a highly unusual set of 
facts and circumstances: The most sweeping PHE to occur in over a 
century. The public health threat caused by COVID-19, the disease 
caused by the SARS-CoV-2 virus, is substantial. Global demand for 
certain devices, such as ventilators, has increased significantly and 
is a critical part of the response to the COVID-19 outbreak. FDA's 
COVID-19 PHE guidance documents provide information, recommendations, 
and policies to help address the urgent need for certain devices and 
help expand the availability of those devices during the COVID-19 PHE.

V. The January 15, 2021, Notice and Reasons for Withdrawal

    On January 15, 2021, HHS published a Notice (the ``January 15, 
2021, Notice'') (86 FR 4088) proposing to exempt 83 class II device 
types and 1 unclassified device type from the 510(k) premarket 
notification requirements. We did not find any evidence that HHS 
consulted with, otherwise involved, or even notified FDA before issuing 
the Notice. Some of these proposed exemptions include device types that 
are indicated for a use in supporting or sustaining human life, such as 
product code NQY (``Ventilator, Continuous, Minimal Ventilatory 
Support, Home Use''). The determinations in the proposal were based 
solely on a tally of adverse events in FDA's Manufacturer and User 
Facility Device Experience database (MAUDE), and the conclusion was 
based on the number of adverse events MAUDE tabulated. The Notice 
stated that ``[g]iven the lack of any adverse event reports in MAUDE 
for [certain of the] class II and the unclassified medical devices . . 
. and the lack of non-death-related [sic] adverse event reports for 
[certain other] class II devices . . . the Department has determined 
that 510(k) premarket notification for the 84 [sic] class II devices 
and the unclassified device . . . is no longer necessary to assure the 
safety and effectiveness of those devices.'' (86 FR 4088 at 4096). The 
January 15, 2021, Notice did not identify any limitations on any of the 
84 proposed exemptions, nor did it indicate that HHS considered whether 
any such limitations were appropriate.
    Upon review, HHS and FDA have determined that the proposed 
exemptions in the January 15, 2021, Notice were published without 
adequate scientific support, that the Notice contained errors and 
ambiguities, and that the Notice is otherwise flawed, as described 
below. This review was prompted primarily by two things. One is that 
staff and leadership in FDA's Center for Devices and Radiological 
Health that conduct regulatory oversight of these products identified 
several issues described below and brought them to the Department's 
attention. The other is that HHS has received dozens of inquiries about 
the January 15, 2021, Notice, as part of comments on the Notice 
submitted to the docket as well as inquiries sent to the contact listed 
in that Notice, or to various FDA staff and FDA program email 
addresses. For example, there were many comments and inquiries asking 
about various potential errors and ambiguities, such as about 
mismatched product descriptions, product codes, and regulatory 
citations.
    The January 15, 2021, Notice relied solely upon adverse event 
reports in MAUDE in determining that a 510(k) is no longer necessary to 
assure the safety and effectiveness of the devices. Although adverse 
event reports are a valuable source of information, the reports have 
limitations, as noted in the January 15, 2021, Notice, including the 
potential submission of incomplete, inaccurate, untimely, unverified, 
or biased data. In addition, the incidence or prevalence of an event 
cannot be determined from adverse event reports alone, due to 
underreporting of events, inaccuracies in reports, lack of verification 
that the device caused the reported event, and lack of information 
about frequency of device use. As noted by several commenters, reliance 
on adverse event reports in MAUDE is an inappropriate basis for 
exemption because, for example, adverse events may be underreported for 
certain devices, and a low number of reports in MAUDE may reflect the 
low number of marketed devices, and not necessarily the risk of injury. 
In addition, relying exclusively on MAUDE data leaves out other 
important information regarding risk. For example, FDA routinely 
considers recall information as part of its risk analyses, including 
for class II 510(k) exemptions.
    Moreover, to exempt a device from 510(k) under the standard set 
forth in section 510(m)(2) of the FD&C Act, FDA must determine that a 
510(k) submission is no longer necessary to assure the safety or 
effectiveness of the device. Not only is adverse event data inadequate 
on its own for assessing safety, it may provide little or no 
information about effectiveness, for purposes of proposing exemptions. 
As some comments noted, inaccurate readings from certain devices, 
including tonometers, electrocardiographs, electroencephalographs, 
seizure monitoring systems, vestibular analysis apparatus, or cerebral 
oximeters may contribute to erroneous clinical and surgical decisions, 
but may not be reflected in MAUDE.
    To the extent adverse event data is a relevant factor in 
determining whether to exempt a class II device type from premarket 
notification, the January 15, 2021, Notice reflects an improperly 
narrow consideration of the adverse event data. The Notice proposed to 
exempt 50 class II device types based solely on a lack of death-related 
adverse event reports available in MAUDE for the time period searched, 
while failing to consider adverse event reports submitted under other 
event types, including ``injury'' and ``malfunction.'' In just one 
example, table 4.2 of the Notice states that for product code MOS 
(erroneously described as ``Implanted Subcutaneous Securement 
Catheter''), there were zero MAUDE reports submitted under ``death,'' 
but there were 73 other reports, including 13 submitted under 
``malfunction'' and 52 under ``injury.'' While adverse event data 
should not provide the sole basis for an exemption, FDA has considered 
all adverse event data relevant to its determinations and has not 
limited its consideration to only those adverse event reports submitted 
under the ``death'' event type. This is because, for example, device 
malfunctions or injuries that do not result in death still inform 
whether a 510(k) submission is necessary to assure the safety or 
effectiveness of the device. In addition, the event types in MAUDE are 
supplied by the submitter, and thus death-related adverse events may be 
mistakenly submitted under other event types, such as ``Other,'' if any 
event type is specified at all.
    In considering whether exemption from 510(k) is appropriate for 
class II device types, FDA has consistently taken into account both 
safety and

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effectiveness, and considers the factors identified in the January 21, 
1998, FR notice (63 FR 3142), and as explained in FDA's guidance 
``Procedures for Class II Device Exemptions from Premarket 
Notification,'' including whether (1) the device has had a significant 
history of false or misleading claims or of risks associated with 
inherent characteristics of the device; (2) any device characteristics 
necessary for its safe and effective performance are well established; 
(3) any changes in the device that could affect safety and 
effectiveness will either (a) be readily detectable by users by visual 
examination or other means such as routine testing, before causing 
harm, or (b) not materially increase the risk of injury, incorrect 
diagnosis, or ineffective treatment; and (4) any changes to the device 
would not be likely to result in a change in the device's 
classification. These factors are relevant to understanding whether a 
premarket notification is necessary to assure the safety and 
effectiveness of a device. FDA has consistently used them since 1998, 
when section 510(m) was first enacted. However, these factors were not 
considered as part of the January 15, 2021, Notice. As mentioned above, 
the January 15, 2021, Notice only considered one piece of information--
MAUDE data--which is a drastically narrower approach to the evaluation 
of whether a device should be exempt than the factors FDA has 
consistently considered.
    It was also an error for HHS to propose to exempt the unclassified 
device type with product code LXV from the premarket notification 
requirements. Unclassified devices require submission of a 510(k) 
premarket notification. The January 15, 2021, Notice proposes to exempt 
this unclassified device type from 510(k) under the process and 
standard of 510(m). Section 510(m), however, provides only for the 
exemption of class II devices. Unclassified devices are not class II 
devices. Therefore, 510(m) does not provide the standard or process for 
exemption of unclassified devices. The January 15, 2021, Notice did not 
cite to any other statutory provision that authorizes the exemption of 
unclassified devices from 510(k).
    As noted, the January 15, 2021, Notice contained numerous errors 
and ambiguities, such as mismatched product descriptions, product 
codes, and regulatory citations. For example, table 6 in the Notice 
lists the 84 devices it proposed to exempt. One entry gives the Device 
description as ``Oxygenator, Long Term Support Greater than 6 Hours,'' 
the Product code as ``BZG,'' and the section in 21 CFR as ``868.1840.'' 
The same table has a second listing for ``Oxygenator, Long Term Support 
Greater than 6 Hours,'' this one giving the Product code as ``FXY'' and 
the section in 21 CFR as ``878.4040.'' However, ``Oxygenator, Long Term 
Support Greater than 6 Hours'' is Product code BYS and is classified in 
21 CFR 870.4100. These errors and ambiguities make it difficult or 
impossible in some circumstances to discern which class II devices the 
Notice is proposing to exempt, as noted by some commenters.
    Finally, we did not find evidence that HHS consulted with or 
otherwise involved FDA in its proposed exemption or the issuance of the 
January 15, 2021, Notice. Section 1003(d) of the FD&C Act (21 U.S.C. 
393(d)) provides that the Secretary ``shall be responsible for 
executing'' the FD&C Act ``through the [FDA] Commissioner.'' Here, the 
January 15, 2021, Notice is clearly an action ``executing'' the FD&C 
Act. Moreover, it is particularly important that FDA have at least some 
level of involvement in this type of an action given the expertise 
needed in evaluating whether a submission under 510(k) of the FD&C Act 
is necessary to assure the safety and effectiveness of a device.
    For these reasons, HHS and FDA are withdrawing the proposed 
exemptions of the 83 class II devices and 1 unclassified device 
published on January 15, 2021, at 86 FR 4088. Elsewhere in this issue 
of the Federal Register, HHS and FDA are stating their belief that the 
class I devices that are the subject of the January 15, 2021, Notice 
meet the criteria for reserved class I devices and that it is 
appropriate to reverse the determination of exemption for those 
devices.

    Dated: April 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07760 Filed 4-15-21; 8:45 am]
BILLING CODE 4164-01-P