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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
included in the summary of each clinical investigation under 860.220a13ii this final rule renumbers proposed 860.234a13ii as 860.220a13ii because the commenter asserts it is unnecessarily restrictive and repetitive to require this information in the summary when the same information is also required in the technical sections of the De Novo request under 860.220a15iii this final rule renumbers proposed 860.234a15iii as 860.220a15iii.
Response 36 FDA does not agree with this comment. The summary of technical data required under 860.220a13 is intended to be analogous to an executive summary of each study used to support the De Novo request and would typically include less information than that submitted in the technical sections. The information required in the technical sections 860.220a15 is the more detailed and complete information regarding each study. While it may be appropriate to cross reference the information from the summary section 860.220a13, FDA does not believe cross referencing the information in the summary required under 860.220a13 would be sufficient to provide all of the required technical information to support marketing authorization.
Because the summary information required for clinical investigations submitted in the De Novo request may include information other than the specific items listed in 860.220a13ii and because it is intended to be a higher level summary of the data in the technical sections, we do not believe the required summary is unnecessarily restrictive or repetitive.
Comment 37 A few comments ask FDA to revise the nonclinical testing paragraph 860.220a15i, this final rule renumbers proposed 860.234a15i as 860.220a15i by moving the as appropriate qualifier forward in the sentence.
Response 37 FDA agrees that moving the words as appropriate forward in the sentence would clarify the requirement. We are revising paragraph 860.220a15i accordingly.
Comment 38 A few comments ask FDA to revise the requirements for a summary of studies and the technical sections in a De Novo request to clarify that a statement regarding compliance with part 58 is only necessary for studies that are required to comply with part 58 because the commenters state that many nonclinical studies are outside the scope of part 58 if they do
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not involve the use of animals or other test systems.
Response 38 FDA agrees that some nonclinical studies that may be submitted to support a De Novo request, such as certain electromagnetic compatibility testing, are not subject to part 58. In response to these comments, FDA is revising 860.220a15i this final rule renumbers proposed 860.234a15i as 860.220a15i to clarify that a statement of compliance with part 58 or a brief statement of the reason for noncompliance is required only for nonclinical studies subject to part 58.
Comment 39 A comment asks FDA
to revise the requirements for submitting results of clinical investigations involving human subjects 860.220a15iii, this final rule renumbers proposed 860.234a15iii as 860.220a15iii to clarify that clinical investigations are not required in all cases to support the De Novo classification decision. Comments also requested revisions to this provision to clarify that some clinical investigations submitted in the De Novo request may be ongoing e.g., clinical investigations that are ongoing but for which all subjects have reached the primary endpoint. These comments also ask FDA to revise the proposed regulatory text to refer to records instead of copies of individual subject report forms because the commenters assert that many clinical investigations are carried out with validated electronic data capture systems and individual human subject forms are not used.
Response 39 FDA agrees that clinical evidence may not always be required in a De Novo request to support a determination that general controls or general and special controls provide a reasonable assurance of safety and effectiveness of the device and device type. However, we believe no clarification is needed regarding whether a clinical investigation involving human subjects is required because that determination will be specific to the De Novo request. If the requester believes that information regarding clinical investigations required under 860.220a15iii this final rule renumbers proposed 860.234a15iii as 860.220a15iii, or other information required under 860.220a15i this final rule renumbers proposed 860.234a15i as 860.220a15i, is not applicable to its device, then the requester may include a justification for omitting that information from the De Novo request in accordance with 860.220c this final rule renumbers proposed 860.234c as
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860.220c. If De Novo requesters have questions about the process for submission and review of a De Novo request for their device, we recommend that they consult FDAs guidance, De Novo Classification Process Evaluation of Automatic Class III Designation Ref. 5 and request a meeting with FDA
through the Q-submission program.
Meetings between the requester and FDA allow for an open discussion and exchange of technical, scientific, and regulatory information that can help build a common understanding of FDAs initial expectations regarding clinical studies and nonclinical studies related to the De Novo request Ref. 13.
FDA recognizes that some De Novo requests include results from clinical investigations that remain ongoing, such as a study that has a pre-specified interim analysis of safety or effectiveness data. However, FDA
believes the regulatory text in 860.220a15iii would already permit inclusion of such results and does not believe a revision to the regulatory text is necessary.
We also recognize that some comments raise a concern that individual subject forms are not used in many clinical investigations. While the commenters do not object to providing individual subject information for those subjects who died during a clinical investigation or who did not complete the investigation, the commenters suggest that the term records would better reflect electronic source data instead of the term copies of such forms. We agree with the comments that data capture and collection methods used in clinical investigations have evolved over time. FDA has published guidance, Use of Electronic Health Record Data in Clinical Investigations, addressing data capture in clinical investigations that do not use paper case report forms Ref. 14. FDA
interprets the term individual subject form, as used in this rule, to include the different electronic or paper formats used to capture individual subject data.
Therefore, we do not believe that using the term record is necessary.
Comment 40 A comment asks FDA
to require that the technical sections of a De Novo request include a protocol and a report for all clinical investigations and laboratory studies to make the requirements for the technical sections more consistent and less confusing.
Response 40 We agree that additional clarity regarding technical sections requirements for nonclinical studies would be helpful. Protocols and complete test reports generally are necessary to provide sufficient detail
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