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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
rule renumbers proposed 860.234b as 860.220b to permit the requester to file a general authorization allowing another person to submit additional pertinent information. According to the commenter, this would allow De Novo requesters to avoid the need for case-bycase authorization.
Response 45 FDA disagrees with this comment and believes the commenter misunderstands the circumstances in which FDA requires an authorization.
The provision in 860.220b addresses situations in which a De Novo request references information in FDAs files that was submitted by someone other than the requester. For FDA to consider that information as part of the De Novo request, we require a written authorization from the person originally submitting that information to FDA that authorizes the use of the information in the De Novo request. Because the authorizer determines the scope of the authorization, it can be as broad or as limited as the authorizer wants the authorization to be. The comment seems to suggest that the requester should be able to provide authorization for the De Novo request to reference information in FDAs files submitted by others, but the submitters of the data are the ones in a position to authorize references to it.
Comment 46 A few comments request FDA to revise the requirement to update a pending De Novo request with new information from ongoing or completed studies that may reasonably affect an evaluation of the safety and effectiveness of the device as it becomes available 860.220d, this final rule renumbers proposed 860.234d as 860.220d because the commenters assert FDA should allow time for data aggregation and assessment. The comments suggest that FDA should require such information as agreed upon with the De Novo requester or as specified in a protocol.
Response 46 FDA disagrees with these comments. The comments assume incorrectly that for each ongoing or completed nonclinical and/or clinical study, there exists a protocol that has timeframes for reporting new safety and effectiveness information to FDA or an agreement specifying when new safety and effectiveness information must be submitted to update a pending De Novo request. FDA is also concerned that specifying a set time period for updating the De Novo request would be problematic because the importance of the data required to be reported may vary. For example, FDA would be particularly interested in receiving quickly information that concerns the death of a human subject. Updating a De Novo request in accordance with pre-set
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periods in a protocol or agreement could also result in FDA making a decision on a De Novo request without key, available safety and effectiveness information. For example, an unplanned review of the safety data could have implications on the statistical validity of a study.
I. Comments and FDA Response on Criteria for Accepting a De Novo Request Comment 47 A comment states the requirements in 860.230 this final rule renumbers proposed 860.245 as 860.230 should be moved to FDAs guidance, Acceptance Review for De Novo Classification Requests FDA
draft guidance published October 30, 2017. Another comment recommends finalizing FDAs guidance, Acceptance Review for De Novo Classification Requests, concurrently with finalizing the rule.
Response 47 FDA disagrees with this comment because FDAs requirements are based on its statutes and regulations.
FDA guidance provides non-binding recommendations. Regulations are necessary because they allow the Agency to enforce the requirements therein. For this reason, we decline to remove the accepting a De Novo request requirements, including those in 860.230, from this regulation.
FDAs Acceptance Review for De Novo Classification Requests guidance was finalized on September 9, 2019 84
FR 47310 Ref. 16, so the comment requesting concurrent publication is moot.
Comment 48 A comment requests FDA to clarify that references to 15
days signify calendar days because it will enhance De Novo requester planning.
Response 48 FDA declines to clarify in the codified but confirms that it interprets 15 days to mean 15
calendar days. This interpretation is consistent with FDAs final guidance entitled, Acceptance Review for De Novo Classification Requests Ref. 16, which explains that the 15 days are calendar days. It is also consistent with our interpretation of days as used in analogous regulations for PMAs and 510ks.
J. Comments and FDA Response on Granting or Declining a De Novo Request Comment 49 A comment objects to developing a new lexicon for De Novo requests i.e., grant or decline and asks FDA to use the term approval because the commenter asserts that CDRH
approves both De Novo devices and PMA devices for marketing based on
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a determination that they are safe and effective for their intended use.
Response 49 We disagree with this comment. The term decline is language from section 513f2 of the FD&C Act, and FDA believes the term grant is appropriate, given that section 513f2 of the FD&C Act addresses a request for classification.
In addition, FDA does not make identical determinations when approving a PMA or granting a De Novo request. The statutory standards for approval of a PMA include a showing of reasonable assurance that the device is safe and effective see section 515d of the FD&C Act. FDA will grant a De Novo request and classify the device as either class I or class II when the request demonstrates that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness see section 513a and f2 of the FD&C Act.
Comment 50 To be consistent with section 513f2C of the FD&C Act, a few comments requested that FDA
revise the provision regarding publication in the Federal Register of the notice announcing the classification of the device to state that the publication will occur within 30 days of granting the request.
Response 50 FDA agrees to revise 860.260a2 this final rule renumbers proposed 860.289a2 as 860.260a2 to reflect the statutory timeframe for publishing a notice in the Federal Register announcing the classification of a device under section 513f2C of the FD&C Act. We are revising 860.260a2 accordingly to add the phrase within 30 days after the issuance of an order granting the De Novo request. We note that the classification of a device, including any special controls, is effective on the date the order letter is issued granting the De Novo request. Once the De Novo request is granted, the device may serve as a predicate device to which another device can claim substantial equivalence. FDA places copies of such orders on its website.
Comment 51 A comment on the proposed provisions for declining a De Novo request notes that stating FDA
may issue written notice declining a request suggests there is an alternative to issuing a written notice and asks FDA
to describe the alternative.
Response 51 FDA intended to outline the grounds for which FDA may decline a De Novo request in proposed 860.289b this final rule renumbers proposed 860.289b as 860.260c and moves the grounds for which FDA
may decline a De Novo request into
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