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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
classification decision. A commenter states the term principal components is appropriate because it signals that the submitter should identify the devices primary components but need not identify every component. Another commenter similarly suggests the term major components would be appropriate.
Response 20 FDA disagrees that ingredient is an atypical term for a device. For example, in vitro diagnostic device labels generally are required to include the quantity, proportion, or concentration of each reactive ingredient for a reagent 21 CFR
809.10a3.
In addition, FDA does not agree with requiring only a devices principal or major components to be described in a De Novo request. FDA is requesting identification of all functional components or ingredients that comprise the subject device or combination product so that FDA has sufficient understanding of the device to evaluate whether general controls or general and special controls are sufficient to provide reasonable assurance of safety and effectiveness.
We would consider any component of the device relating to how the device operates be a functional component. It was not our intent to limit the identification of the components or ingredients of the device or combination product. To that end, we disagree with the commenters proposed edits to require identification of only major or principal components.
Comment 21 Comments on the summary of studies this final rule renumbers proposed 860.234a13ii as 860.220a13ii, the technical sections this final rule renumbers proposed 860.234a15i and iii as 860.220a15i and iii, and the bibliography this final rule renumbers proposed 860.234a16i as 860.220a16i that are part of the required content of a De Novo request ask that FDA limit the required information to that necessary to determine the classification of the device. The commenter states that it is necessary to clarify that data unrelated to classification of the device e.g., for other indications do not need to be submitted and that the focus of the application is to determine the classification of the device.
Response 21 FDA does not agree with these comments and does not believe the requested clarifications are necessary. Under the FD&C Act, FDA
determines the classification of a device that is the subject of a De Novo request section 513f2 of the FD&C Act. The requirements for the content of a De
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Novo request reflect the information that, in FDAs experience, generally is necessary to determine if general or general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness of the device that is the subject of the De Novo request. To the extent the requester believes that certain required content for a De Novo request is not applicable to its device, the requester has the option under 860.220c this final rule renumbers proposed 860.234c to 860.220c to omit that information and submit a statement that specifies the omitted information and justifies the omission. FDA will notify the requester if it does not accept the justification.
Further, 860.220a15 this final rule renumbers proposed 860.234a15 as 860.220a15
already specifies that the required technical sections must include data and information in sufficient detail to permit FDA to determine whether to grant or decline the De Novo request.
Therefore, we believe it is already clear the information required in the technical sections under 860.220a15i and iii the final rule renumbers proposed 860.234a15i and iii as 860.220a15i and iii and the related summary of studies under 860.220a13 the final rule renumbers proposed 860.234a13 as 860.220a13 is information focused on FDAs classification determination.
In addition, the bibliography of published reports required under 860.220a16i the final rule renumbers proposed 860.234a16i as 860.220a16i is limited to reports that concern the safety or effectiveness of the device. Published reports concerning the safety or effectiveness of the device that is the subject of the De Novo request would be useful to FDAs evaluation of the request.
Comment 22 Some comments object that FDAs proposed requirements for the data and information submitted in a De Novo request are overly broad or potentially confusing. One commenter supports requirements for a thorough review of existing data but requests that the requirement to submit all available data . . . should be clarified to indicate that which is reasonably attainable by the De Novo requester.
Other commenters request that FDA
change the phrase known or reasonably known in certain provisions of 860.220a this final rule renumbers proposed 860.234a to 860.220a to known or reasonably available to the requester. These
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commenters indicate that the known or reasonably known standard does not clarify to whom the required information is known or reasonably known. A commenter also indicates that the proposed language could lead FDA
reviewers to decide a De Novo requester is hiding something if the submission lacks information known to the reviewer but not the requester. Another commenter states that use of the term reasonably available instead would imply that the sponsor must engage in reasonable effort to obtain the relevant information.
Response 22 FDA did not include provisions in the proposed rule using the phrase all available data as one comment suggests, but we believe limiting all of the required information for a De Novo request to that reasonably attainable by the requester is inappropriate. In some cases, for example, a requester may know of studies or reports concerning the safety or effectiveness of the device but be unable to obtain them for some reason e.g., the requester must pay to gain access to a registry containing the relevant data. In these cases, it is still useful to provide to FDA the information about such studies or reports that is known or reasonably should be known to the requester, even if complete information about or copies of such studies or reports is unavailable to the requester. For example, FDA may have a greater ability to access a publication with more complete information.
In response to these comments, FDA
is revising 860.220a7 and 9 this final rule renumbers proposed 860.234a7 as 860.220a7 and renumbers 860.234a11 as 860.220a9 to clarify that the information required is that known to or that reasonably should be known to the requester. The intent of requiring a De Novo request to include information that is known or reasonably known to the requester is to ensure that the requester engages in a reasonable effort to provide relevant information and does not omit information important to FDAs determination to grant or decline the De Novo request because of a failure to conduct reasonable searches for such information. As explained in the proposed rule, for example, the summary of known or reasonably known probable risks to health associated with the use of the device required in the De Novo request under 860.220a9 should be based on the best available information at the time of submission of the De Novo request. 83
FR 63127 at 63133 These requirements help ensure that FDAs evaluation of a
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