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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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, 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. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A 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 FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs 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.

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Reclassification Petitions for Medical Devices OMB Control Number 09100138
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,
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class II special controls, and class III
premarket approval section 513a1
of the FD&C Act 21 U.S.C. 360ca1.
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 513e 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 513e of the FD&C Act from rulemaking to an administrative order process. To reclassify a device under section 513e 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 510k submission, and submission of a PMA is not required until FDA has issued a final order requiring premarket approval section 515b of the FD&C Act 21
U.S.C. 360eb. 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 515b of the FD&C Act, as amended by FDASIA.
Under the FD&C Act, FDAs 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 515b2 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
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the device; or 2 publish a notice in the Federal Register terminating the proceeding and initiate a reclassification proceeding based on new information section 515b3 of the FD&C Act, as amended by FDASIA; see section 513e 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 515b 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 513f1 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 513f2 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 513i 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 513f3 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 860.134c 21 CFR 860.134c. The reclassification order may, as appropriate, establish special controls to provide reasonable assurance of the safety and effectiveness of the device 860.134d.
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 520l2 of the FD&C Act 21
U.S.C. 360jl2. The process for reclassification of transitional devices initiated by FDA is detailed in 21
CFR 860.136c. This process consists of a proposed reclassification order, optional panel consultation, and a final
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