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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
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advocacy groups; law firms; and individuals. While several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule: To establish regulations implementing the De Novo classification process. Comments raise concerns or request clarification regarding several issues, including:
De Novo request information disclosure, facility inspections, devices that collect protected health information, training of FDA reviewers, the definitions, the De Novo request format, the De Novo request content, the criteria for accepting a De Novo request, the criteria for declining a De Novo request, the availability of the De Novo classification process for combination products, and the information needed to support FDAs determination to grant a De Novo classification request.
C. General Overview of Final Rule FDA considered all comments received on the proposed rule and made changes, primarily for clarity and accuracy and to reduce burden in meeting regulatory requirements. On its own initiative, FDA is renumbering the sections to make them easier for De Novo requesters and the public to research and use. On its own initiative, FDA is also making minor technical changes to make the regulatory history, withdrawal, nonclinical studies, and classification summary provisions clearer. FDA also changed the word guidance to guidelines in the definition of Class II at 860.3 21 CFR
860.3 on its own initiative for consistency with the language used in section 513a1B of the FD&C Act 21
U.S.C. 360c a1B and with 860.123
21 CFR 860.123 in the final rule.
Finally, on its own initiative, FDA is adding requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the FD&C
Act that are submitted in accordance with section 513g of the FD&C Act, to the regulatory history information required to be included in a De Novo request under proposed 860.234a3
21 CFR 860.234a3 see 860.220a3 in the final rule. In the preamble of the proposed rule, FDA
described section 513g requests for information as one of the submissions it was proposing to require requesters to identify as part of the regulatory history
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section of a De Novo request see 83 FR
63127 at 63132. However, a reference to section 513g of the FD&C Act was inadvertently omitted from the proposed regulatory text included in the proposed rule. The changes from the proposed rule include the following revisions, additions, and removals.
Renumber the proposed De Novo section numbers as follows:

TABLE 1RENUMBERED SECTIONS
Proposed section No.

Renumbered section No.

Section name
860.201

860.200

860.223

860.210

860.234

860.220

860.245

860.230

860.256

860.240

860.267

860.250

860.289

860.260

Purpose and applicability.
De Novo request format.
De Novo request content.
Accepting a De Novo request.
Procedures for review of a De Novo request.
Withdrawal of a De Novo request.
Granting or declining a De Novo request.

Revise the De Novo request confidentiality provision 860.5g to clarify that after an order granting a De Novo request is issued, data and information in the De Novo file that are not exempt from release under the Freedom of Information Act FOIA 5
U.S.C. 552 are immediately available for public disclosure; and to replace certain references to De Novo request with De Novo file.
Revise the De Novo format requirements as follows:
Remove the requirement to cite the volume number in the table of contents if the De Novo request consists of only one volume, remove the requirement to provide a fax number when submitting a De Novo request, and clarify that the De Novo request must be submitted as a single version in electronic format.
Revise the De Novo content requirements as follows:
Add section 513g requests for information to the regulatory history requirement in proposed 860.234a3
see 860.220a3 and change the term use to device in the regulatory history requirement so the text more accurately refers to an application for humanitarian device exemption.
Revise the order of the proposed requirements for the content of a De
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Novo request in proposed 860.234a9 through 11 see 860.220a9 through 11 in the final rule.
Revise 860.220a7 and a9
this final rule renumbers proposed 860.234a7 as 860.220a7 to clarify that the information required is that known to or that reasonably should be known to the requester.
Remove laboratory to clarify 860.220a13i and a15i this final rule renumbers proposed 860.234a13i and a15i to 860.220a13i and a15i requires a summary of each nonclinical study.
Move the phrase, as appropriate, in 860.220a15i to clarify that not all of the identified nonclinical studies may be applicable to the subject device.
Revise 860.220a15i to clarify that a De Novo requester must include a protocol and complete test report for each nonclinical study.
Revise 860.220a15i to clarify that a De Novo request must only include a statement regarding compliance with good laboratory practice GLP requirements in part 58
21 CFR part 58 for nonclinical studies that are subject to part 58.
Revise the provisions for withdrawal of a De Novo request to make minor technical changes.
Revise the provisions for granting a De Novo request to specify that FDA
will publish a notice of the classification order in the Federal Register within 30 days after granting the request.
Revise the provisions for declining of a De Novo request to clarify that FDA
will decline a De Novo request by written order and moves the grounds for which FDA may decline a De Novo request from 860.260b into 860.260c.
IV. Legal Authority The FD&C Act establishes a comprehensive system for the regulation of medical devices intended for human use. Among the provisions that provide authority for this final rule are sections 201h, 503g, 513a and f, 701a, and 704 of the FD&C Act 21 U.S.C. 321h, 353g, 360ca and f, 371a, and 374.
This final rule establishes regulations to implement the De Novo classification process created by section 207 of FDAMA Pub. L. 105115 and amended by section 607 of FDASIA Pub. L. 112
144 and section 3101 of the Cures Act Pub. L. 114255.

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