[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50132-50134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1529]


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with reclassification of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by November 8, 2021.

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 November 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 8, 2021. 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-2013-N-1529 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reclassification Petitions for 
Medical Devices.'' Received comments, those filed in a timely manner 
(see ADDRESSES), 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, 240-402-7500.
     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.govinfo.gov/content/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

[[Page 50133]]

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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 which 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 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

[[Page 50134]]

reclassification order published in the Federal Register following 
consideration of comments and any panel recommendations or comments.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
          21 CFR section; information collection activity               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Sec.   860.123; supporting data for reclassification petitions.....               6                1                6              497           2,982
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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: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19221 Filed 9-3-21; 8:45 am]
BILLING CODE 4164-01-P