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lotter on DSK11XQN23PROD with RULES1

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations regarding the results of a nonclinical study to permit FDA to determine whether to grant or decline the De Novo request. However, we are revising 860.220a15i this final rule renumbers proposed 860.234a15i as 860.220a15i to state expressly that these materials must be provided for each nonclinical study submitted in the technical sections of the request.
FDAs guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Ref. 15
discusses the information that should typically be included in test protocols and complete test reports for nonclinical bench performance testing provided in a premarket submission. We note that in cases where a requester is appropriately declaring conformity with a voluntary consensus standard that FDA has recognized pursuant to section 514c of the FD&C Act 21 U.S.C. 360dc to meet applicable requirements, it may not be necessary to submit complete test reports with respect to those requirements. In these cases, the requester may submit a statement of omission for this information in the De Novo request in accordance with 860.220c. However, consistent with section 514c3B of the FD&C Act, FDA may request, at any time, the data or information relied on by a person to make a declaration of conformity with respect to a recognized standard. See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Ref. 11 for more information regarding use of declarations of conformity in premarket submissions.
FDA disagrees with modifying 860.220a15iii to specifically require submission of a clinical investigation report. This provision already describes the supporting information required regarding the results of each clinical investigation, and in our experience, there can be significant variability in the types of information included in reports prepared for clinical investigations. If some or all of the information required under 860.220a15iii is included in a separate clinical investigation report, the requester may include the report in its De Novo request to satisfy those requirements.
Comment 41 A comment asks FDA
to revise the other information provision 860.220a16, this final rule renumbers proposed 860.234a16 as 860.220a16 to limit the information required in the bibliography of all published reports not submitted under the technical sections of the De Novo request 860.220a15,
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this final rule renumbers proposed 860.234a15 as 860.220a15 to those necessary to support the safety or effectiveness of the device because the commenter asserts such reports should be limited to those needed to establish the devices proposed classification, its probable risk, and its probable benefit.
Response 41 We do not agree with limiting the bibliography required under 860.220a16 to that information necessary to support the devices safety or effectiveness. Paragraph 860.220a16i this final rule renumbers proposed 860.234a16i as 860.220a16i requires that the requester submit a bibliography of all adverse or supportive published reports, other than those submitted in greater detail in the technical sections of the De Novo request, that are known to or should reasonably be known to the requester and that concern the safety and effectiveness of the device. The commenters proposed revision would eliminate the requirement to include adverse published reports that may call into question the safety or effectiveness of the device at issue. However, such adverse reports may be important to FDAs assessment of the probable benefits and risks of the device and affect the Agencys classification determination.
Comment 42 A comment supports the requirement to provide a sample of the device, if requested by FDA
860.220a17, this final rule renumbers proposed 860.234a17 as 860.220a17 because it improves transparency. Other comments request that FDA eliminate the language indicating that the Agency may test one or more of the devices because FDA
has traditionally relied on testing by the manufacturer. Another commenter indicated that while providing samples may be appropriate for a high-risk device likely to be reviewed in a PMA, it is unclear that samples are necessary for devices reviewed through the De Novo pathway.
Response 42 FDA disagrees with the comments that suggest limiting the sample requirement and agrees with the comment that the request for samples improves transparency. In many cases, FDA relies on descriptions of a device and testing performed by manufacturers to evaluate safety and effectiveness.
However, there are some situations in which FDA would request a sample of a device reviewed through the De Novo pathway because FDA needs to see or test the device to understand the device and determine if general or general and special controls are sufficient to reasonably assure safety and effectiveness of the device and device
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type. Examples of the situations where a device sample may be requested by FDA for examination or testing include devices intended for use by a lay person that previously have been marketed for use by a physician or other experienced healthcare professional, and devices with novel, complex designs that are difficult to assess solely through written description and/or engineering drawings.
Comment 43 A comment supports the proposed requirement that a De Novo request include labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use 860.220a18, this final rule renumbers proposed 860.234a18 as 860.220a18 because this requirement improves transparency.
Other commenters propose limiting the requirement to not include advertisements because the commenters state advertisements are outside the scope of a class I and class II device review.
Response 43 FDA agrees that the requirement to submit labels, labeling, and advertisements improves transparency. FDA disagrees that review of advertisements is outside the scope of De Novo request review. Under the proposed provision, only labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use are required, and such information is necessary to determine the devices intended use and its safety and effectiveness for the purposes of classification. See, e.g., 860.7b2.
Comment 44 A comment supports the requirement for a requester to provide a list of any required information that is omitted from the De Novo request and a justification for any omission because the commenter states it would ensure completeness of the applicants research and pre-application evaluations.
Response 44 FDA agrees that it is beneficial for the requester to provide a statement identifying and justifying the omission of any information required under 860.220a this final rule renumbers proposed 860.234a as 860.220a and is finalizing the requirement to provide such a statement in 860.220c this final rule renumbers proposed 860.234c as 860.220c. However, we wish to clarify that the omissions statement is not required to be in the format of a list, as the comment suggests.
Comment 45 A comment requests FDA to revise the requirements for incorporation of information in FDA
files by reference 860.220b, this final
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