Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices, 50132-50134 [2021-19221]

Download as PDF 50132 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 24 to 48 hours before the event, registrants will receive an email with the meeting link and a formal calendar invitation. Request to Provide Open Public Comment: During online registration, you may indicate if you wish to make open public comments during the public meeting and which topic(s) you would like to address. All requests to make public comments must be received by October 8, 2021 at 11:59 p.m. Eastern Time. We will do our best to accommodate requests to make public comments. We are seeking to have a broad representation of ideas and issues presented at the meeting. Individuals and organizations with common interests are urged to consolidate or coordinate their comments. FDA will determine the amount of time allotted to each commenter, the meeting day, the approximate time open public comments are to be provided and notify all registrants who requested to make public comments. Streaming Webcast of the Public Meeting: This public meeting will be broadcast via YouTube. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20850. A link to the transcript will also be available on the internet at: https://www.fda.gov/ food/workshops-meetings-webinarsfood-and-dietary-supplements/new-erasmarter-food-safety-summit-ecommerce-ensuring-safety-foodsordered-online-and-delivered. Dated: August 31, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19219 Filed 9–3–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSKJLST7X2PROD with NOTICES [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. The Food and Drug Administration (FDA, Agency, or we) is SUMMARY: VerDate Sep<11>2014 00:30 Sep 04, 2021 Jkt 253001 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: PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 U:\07SEN1.SGM • 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-201509-18/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 07SEN1 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 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, PRAStaff@ fda.hhs.gov. 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. sradovich on DSKJLST7X2PROD with NOTICES 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), VerDate Sep<11>2014 00:30 Sep 04, 2021 Jkt 253001 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 PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 U:\07SEN1.SGM 50133 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 FDAinitiated 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 (§ 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 (§ 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 07SEN1 50134 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 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 21 CFR section; information collection activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours § 860.123; supporting data for reclassification petitions ...... 6 1 6 497 2,982 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES the third column under ‘‘Instructions,’’ ‘‘Docket No. FDA–2020–N–1648N’’ is changed to ‘‘Docket No. FDA–2021–N– 0944’’. 2. On page 43666, in the first column, the DATES portion of the document is changed to: ‘‘The meeting will be held on September 17, 2021, from 10 a.m. to 3 p.m. Eastern Time.’’ This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: August 31, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. Food and Drug Administration [Docket No. FDA–2021–N–0944] [FR Doc. 2021–19216 Filed 9–3–21; 8:45 am] Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Notice. [Docket No. FDA–2021–N–0918] The Food and Drug Administration (FDA) is correcting a notice entitled ‘‘Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ The document announced a meeting of the Pediatric Advisory Committee. The document was published with the incorrect docket number and end time of the meeting. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, August 10, 2021, in FR Doc. 2021–16984 (86 FR 43666), the following corrections are made. 1. On page 43666, in the first column, in the header of the document, and in SUMMARY: sradovich on DSKJLST7X2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 00:30 Sep 04, 2021 Jkt 253001 Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 labeling requirements for prescription drugs. DATES: Submit either electronic or written comments on the collection of information by November 8, 2021. SUMMARY: PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 U:\07SEN1.SGM 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. ADDRESSES: 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. 07SEN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
          21 CFR section; information collection activity               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   860.123; supporting data for reclassification petitions.....               6                1                6              497           2,982
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

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