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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
intended or that similarly affect the structure or function of the body is one of the factors FDA considers in its benefit-risk assessments to determine the appropriate classification for a device. For example, for a device indicated to treat a rare condition for which there are no alternative treatments, FDA may accept greater uncertainty in the evidence regarding the devices probable benefits and probable risks. Furthermore, FDA does not agree with the assumption that a standard of care exists for all diseases or conditions for which a device is intended.
Comment 29 Comments request that FDA rearrange the order of the provisions in proposed 860.234a9
through 11 this final rule renumbers proposed 860.234a9 as 860.220a11 and this final rule renumbers proposed 860.234a11 as 860.220a9. Commenters suggest that the risks and mitigations form the basis for the classification recommendation and accordingly request that the Summary of risks and mitigations provision proposed 860.234a11 precede the Classification recommendation provision proposed 860.234a9.
Commenters further suggest that the Proposed special controls provision proposed 860.234a10 should immediately follow the Summary of risks and mitigations provision to demonstrate whether specific mitigations are general and/or special controls.
Response 29 The order in proposed 860.234a9 through 11 follows the order in which section 513f2Av of the FD&C Act discusses corresponding items. However, we believe the commenters proposed changes make sense. Accordingly, we are revising the order of the paragraphs as follows:
860.220a9 Summary of risks and mitigations;
860.220a10 Proposed special controls; and 860.220a11 Classification recommendation.
Comment 30 A comment supports the requirement for a summary of known or reasonably known probable risks, while another comment suggests that the De Novo request include both a summary and a discussion of the probable risks and mitigations identified through a formal risk analysis.
Response 30 FDA agrees with the comment supporting the requirement for a De Novo request to include a summary of known or reasonably known probable risks, but FDA believes that requiring both a summary and a discussion of these probable risks and
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proposed mitigations is unnecessary.
The De Novo request will be required to summarize probable risks to health associated with use of the device that are known or should reasonably be known to the requester and the proposed mitigations. For each mitigation measure that involves specific performance testing or labeling, the request must reference the associated section or pages of the supporting information, such as supporting protocols and/or testing data. FDA believes such information is sufficient to assist the Agency in identifying the probable risks to health and in evaluating the proposed risk mitigation measures to determine whether general controls or general and special controls can provide reasonable assurance of safety and effectiveness.
Furthermore, FDA requires a related discussion demonstrating that the probable benefit to health outweighs the probable risks of the De Novo device in 860.220a14 this final rule renumbers the proposed 860.234a14 as 860.220a14.
Comment 31 A comment requests that FDA revise the standards paragraph to clarify that De Novo requesters are not required to declare conformity to standards referenced in the De Novo request.
Response 31 The standards paragraph at 860.220a12 this final rule renumbers the proposed 860.234a12 as 860.220a12
does not require that De Novo requesters submit a declaration of conformity to the referenced standard, so the requested clarification is not necessary.
See our guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Ref. 11 for additional information on how to use consensus standards in premarket submissions, including information for those choosing to rely on a consensus standard in a declaration of conformity to meet a premarket submission requirement.
Comment 32 A commenter states that the bibliography of all published reports concerning the safety or effectiveness of the device not submitted under the technical sections of the De Novo request 860.220a16i, this final rule renumbers proposed 860.234a16i as 860.220a16i and the identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness of the device 860.220a16ii, this final rule renumbers proposed 860.234a16ii
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as 860.220a16ii should be provided to FDA for consideration.
Response 32 FDA agrees with the comment and believes that providing a bibliography of all published reports concerning the safety or effectiveness of the device not submitted under the technical sections of the De Novo request, as required by 860.220a16i, and the information on other data, information, or reports relevant to an evaluation of the safety and effectiveness of the device required under 860.220a16ii will be useful to FDAs assessment of safety and effectiveness.
Comment 33 A comment opposed authorizing implanted medical devices for marketing through the De Novo pathway without long-term controlled clinical trials because the commenter states patients deserve long-term safety and effectiveness data. A comment further recommends FDA require information about changes to the research protocol and statistical methodology in the summary of studies submitted in the De Novo request because the commenter states the information is important for evaluating the quality of the study.
Response 33 FDA disagrees that long-term controlled clinical trials must be required across all implanted medical devices. In reviewing a De Novo classification request, studies other than long-term controlled clinical trials may also constitute valid scientific evidence that FDA can rely upon in making a benefit-risk determination for an implanted device, as discussed in our guidance Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Ref. 3. Valid scientific evidence is defined in section 513a3 of the FD&C Act and 860.7c2. Valid scientific evidence, as discussed in 860.7c2, includes partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device. FDA does not believe longterm, controlled clinical studies are necessary to demonstrate that general controls or general and special controls will provide a reasonable assurance of safety and effectiveness for all implantable devices reviewed through the De Novo pathway. For example, some devices are intended to be implanted for a relatively short period of time e.g., 30 days and then removed from the body; longer term clinical data therefore may not be needed to assess
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