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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1

Response 10 We disagree with this proposed revision. This comment is directed specifically to the De Novo classification process, and 860.1
applies to both premarket and postmarket classifications and reclassifications. In addition, we do not agree that the only time we should seek advice from an advisory committee is in cases of high-risk, life-supporting, or life-sustaining devices, or in a classification panel; FDA may refer a matter to an advisory committee because it chooses to do so at its own discretion see our guidance Procedures for Meetings of the Medical Devices Advisory Committee Ref. 7.
For example, the Agency may present a matter before an advisory committee if the matter is of significant public interest or there is additional or special expertise provided by the panel that could assist FDA in its decision making.
Comment 11 A comment asks FDA
to revise the De Novo Purpose and applicability provision the final rule renumbers the proposed 860.201b as 860.200b to clarify that a De Novo request may also be submitted for a group of related devices because a commenter states that, in some cases, more than one related device should be submitted for De Novo classification.
Response 11 FDA disagrees with this comment. Generally, it is not appropriate to bundle multiple devices in a single De Novo request. For example, FDA would not grant a De Novo request that would require FDA to create more than one classification regulation. If an applicant feels that they have a situation where it makes logical sense to bundle multiple devices into one De Novo request, it would be advisable to discuss proactively with FDA in advance of submission of the De Novo request.
D. Comments and FDA Response on De Novo Request Information Disclosure Comment 12 A comment requests that FDA revise the De Novo file confidentiality provision in 860.5g so that it follows the approach for PMAs concerning confidentiality because the commenter asserts requesters are entitled to maintain confidentiality for information submitted to FDA through the De Novo process even if some information relating to the De Novo request has been disclosed publicly.
Another comment requests that FDA
revise the provision regarding disclosure of the existence of a De Novo request before an order granting the request is issued to clarify that such disclosure is governed by the trade secrets and confidential commercial information provisions in 20.61 21

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CFR 20.61. A different comment questions why CDRH could not disclose the existence of a De Novo request and the date of its acceptance for review or the date it was refused.
Response 12 FDA is making minor revisions to refer to the De Novo file instead of the De Novo request in four places in 860.5g for consistency with the language used in 860.5g1 and to align with similar language used in 21
CFR 814.9 regarding confidentiality of information in a PMA file. FDA
otherwise disagrees with the comments requesting revision of the proposed De Novo request confidentiality requirements. The provisions in 860.5g2 and 3 provide that, before an order granting the De Novo request is issued, FDA may not publicly disclose the existence of or data and information contained in a De Novo file, unless such information has already been publicly disclosed or acknowledged by the De Novo requester. Therefore, if a requester publicly acknowledges only the date and existence of a De Novo request submission, that acknowledgment would not, by itself, make underlying data and information in the De Novo file publicly available for disclosure under 860.5g. Further, the requester cannot have confidentiality concerns about information it has already publicly disclosed. This approach is concordant with FDAs general public information regulations at 20.61 and 20.81 21
CFR 20.81. Under 20.61, information submitted to FDA that qualifies as trade secret or confidential commercial information is generally exempt from public disclosure, but 20.81 provides that records otherwise exempt from disclosure are available for public disclosure to the extent that they contain data or information that have previously been disclosed in a lawful manner to any member of the public, other than an employee or consultant or pursuant to other commercial arrangements with appropriate safeguards for secrecy.
Regarding why FDA will not disclose the existence of a De Novo request that has not been publicly disclosed or acknowledged, disclosing the existence of the De Novo request would disclose the requesters intent to market the device. Consistent with FDAs approach in other premarket programs, we generally consider an applicants intent to market a device to be confidential commercial information where the applicant has kept that intent confidential. This approach is supported by the Supreme Courts recent decision in Food Mktg. Inst. v.

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Argus Leader Media, 139 S. Ct. 2356, 2363 2019.
Comment 13 Some comments requested more clarity on how and when data and information may be disclosed by FDA, and some comments suggested that the data and information disclosed after FDA issues an order granting a De Novo request should only be available following a FOIA request. A
commenter also recommended changes to clarify that the requester would have an opportunity to review and redact trade secret information before the release of any data and information in the De Novo request. Another commenter recommended that CDRH
draft and post on its website a summary of the information submitted to support FDAs classification determination and require De Novo requesters to prepare summaries of data and information submitted to support the safety and effectiveness of the specific device that could be posted in FDAs De Novo database to align with public disclosure of 510k and PMA summaries.
Response 13 As discussed in response to the previous comment, prior to sending an order granting the De Novo request to the De Novo requester, FDA will not disclose the data or information contained in the De Novo file, unless the De Novo requester has publicly disclosed or acknowledged such information 860.5g3. To provide more clarity and to help ensure that information exempt from release is appropriately protected, we are revising 860.5g4 to make clear that after FDA sends an order granting the De Novo request to the De Novo requester, FDA may immediately disclose any safety and effectiveness information and any other information in the De Novo file that is not exempt from release under FOIA.
FDA disagrees with the comments requesting FDA to limit the release of data and information contained in a granted De Novo request to situations in which the Agency has received a FOIA
request for that information. FDA
proactively discloses information of interest to the public on a regular basis.
For example, granting a De Novo request allows marketing of the particular device that is the subject of the request, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device section 513f2 of the FD&C Act; Ref.
5. FDA believes that information regarding granted De Novo requests and summaries of safety and effectiveness information that formed the basis of FDAs granting decisions should be publicly posted without waiting to receive a FOIA request for that
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