[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74094-74095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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


