Notice2021-28305
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 86 Issue 247 (Wednesday, December 29, 2021)</title>
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[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74094-74095]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1529]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 28, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0138. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#1a4a485b496e7b7c7c5a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="1b4b495a486f7a7d7d5b7d7f7a35737368357c746d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical Devices
OMB Control Number 0910-0138--Extension
The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes the
following three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness: Class I (general controls), class II (special
controls), and class III (premarket approval) (section 513(a)(1) of the
FD&C Act (21 U.S.C. 360c(a)(1)). To change a device classification, FDA
can initiate a reclassification, or an interested person can petition
FDA to reclassify a device based on new information (section 513(e) of
the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety
and Innovation Act (FDASIA) was enacted, changing the reclassification
process under section 513(e) of the FD&C Act from rulemaking to an
administrative order process. To reclassify a device under section
513(e) of the FD&C Act, FDA must do the following before making the
reclassification final: (1) Publish a proposed order in the Federal
Register that includes the proposed reclassification and a summary of
the valid scientific evidence that supports the reclassification, (2)
convene a device classification panel meeting, and (3) consider
comments from the relevant public docket.
FDASIA also amended the provisions of the FD&C Act authorizing FDA
to require submission of a premarket approval application (PMA) for a
preamendments class III device (referred to as a ``call for PMAs'').
Preamendments devices are devices that were in commercial distribution
before the enactment of the 1976 Amendments. Under the FD&C Act,
preamendments devices classified into class III may be marketed upon
clearance of a 510(k) submission, and submission of a PMA is not
required until FDA has issued a final order requiring premarket
approval (section 515(b) of the FD&C Act (21 U.S.C. 360e(b)). As
amended by FDASIA, the FD&C Act requires that FDA, in its call for
PMAs, publish a proposed order in the Federal Register, hold a
classification panel meeting, and
[[Page 74095]]
consider comments on the proposed order (section 515(b) of the FD&C
Act, as amended by FDASIA).
Under the FD&C Act, FDA's call for PMAs must, among other things,
contain an opportunity for interested persons to request a change in
the classification of the device based on new information (section
515(b)(2) of the FD&C Act). After consideration of comments on the
proposed order and findings, FDA must either: (1) Finalize the call for
PMAs by issuing an administrative order requiring approval of a PMA and
publishing in the Federal Register findings with respect to: (i) 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 product development protocol and (ii) the benefit to the
public from the use of the device; or (2) publish a notice in the
Federal Register terminating the proceeding and initiate a
reclassification proceeding based on new information (section 515(b)(3)
of the FD&C Act, as amended by FDASIA; see section 513(e) of the FD&C
Act).
The FD&C Act, as amended by FDASIA, now requires the use of
administrative orders, rather than rulemaking, when FDA calls for PMAs
for a preamendments device remaining in class III (section 515(b) of
the FD&C Act, as amended by FDASIA).
FDA refers to a device that was not in commercial distribution
before the 1976 Amendments as a postamendments device. Postamendments
devices are classified automatically into class III by statute, without
any rulemaking process (section 513(f)(1) of the FD&C Act). A
postamendments device remains in class III and is subject to the PMA
requirements unless and until: (1) FDA reclassifies the device into
class I or II; (2) FDA issues an order classifying the device into
class I or II via the De Novo classification process (see section
513(f)(2) of the FD&C Act); or (3) FDA issues an order finding the
device to be substantially equivalent to a predicate device that does
not require the filing of a PMA (see section 513(i) of the FD&C Act).
FDA may initiate, or the manufacturer or importer of a device may
petition for, the reclassification of a postamendments device
classified into class III by operation of law (section 513(f)(3) of the
FD&C Act). This FDA-initiated reclassification process consists of a
proposed reclassification order, optional panel consultation, and a
final reclassification order published in the Federal Register
following consideration of comments and any panel recommendations or
comments (Sec. 860.134(c) (21 CFR 860.134(c))). The reclassification
order may, as appropriate, establish special controls to provide
reasonable assurance of the safety and effectiveness of the device
(Sec. 860.134(d)).
Under the 1976 Amendments, Congress classified all those devices
previously regulated as new drugs into class III (generally referred to
as transitional devices). Under the FD&C Act, FDA may initiate, or the
manufacturer or importer of a device may petition for, the
reclassification of a transitional device remaining in class III
(section 520(l)(2) of the FD&C Act (21 U.S.C. 360j(l)(2)). The process
for reclassification of transitional devices initiated by FDA is
detailed in 21 CFR ?860.136(c). This process consists of a proposed
reclassification order, optional panel consultation, and a final
reclassification order published in the Federal Register following
consideration of comments and any panel recommendations or comments.
In the Federal Register of September 7, 2021 (86 FR 50132), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section; information Number of responses per Total annual burden per Total hours
collection activity respondents respondent responses response
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Sec. 860.123; supporting data 6 1 6 497 2,982
for reclassification petitions.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: December 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28305 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P917
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