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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations 860.260c. FDA explained in the preamble to the proposed rule that it was proposing to decline a De Novo request by issuing a written order to the requester 83 FR 63127 at 63137.
However, FDA is revising paragraph 860.260b and c accordingly to clarify this point.
Comment 52 A comment asks FDA
to delete the entire paragraph 860.260c this final rule renumbers proposed 860.289b as 860.260c and moves the grounds for which FDA
may decline a De Novo request into 860.260c on declining a De Novo request because the commenter states the paragraph exceeds the appropriate bases for denial of a De Novo request, which the commenter identifies as the device is inappropriate for classification into class I or class II, or there is a legally marketed predicate device.
Response 52 FDA disagrees with this comment. Section 860.260c this final rule renumbers proposed 860.289b as 860.260b and moves the grounds for which FDA may decline a De Novo request into 860.260c explains FDAs interpretation and implementation of the statutory grounds for declining a De Novo request, which does not rely upon only section 513f2Aiv of the FD&C Act. For example, if a product is not a device within the meaning of section 201h of the FD&C Act or a combination product as defined at 3.2e 21 CFR 3.2e, then FDA may decline to grant the De Novo request.
As noted in the proposed rule 83 FR
63127 at 63137, FDA generally intends to decline a De Novo request for a combination product that does not have a device primary mode of actionsee 3.2m. However, a De Novo request may be appropriate, for example, for the device constituent part of such a combination product if the constituent parts of the combination product are to be distributed separately see 3.2e3
through 4, and the other constituent part drug or biological product of the combination product is to be marketed under its own, separate application i.e., abbreviated new drug application, NDA, or biologics license application.
Comment 53 A few comments request that FDA delete the entire paragraph on declining a De Novo request because the device labeling does not comply with parts 801 and 809 21
CFR parts 801 and 809 because the commenters state it is outside the scope of the De Novo classification process to deny classification based on the devices labeling.
Response 53 FDA disagrees with these comments. Parts 801 and 809 are general controls, and whether the device
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complies with general controls is necessary to determine whether it is of low to moderate risk for the purposes of classification. FDA may decline a De Novo request if it determines that the device submitted is not of low to moderate risk, or that general controls would be inadequate to control the risk and special controls to mitigate the risks cannot be developed. Whether the devices labeling complies with the requirements in parts 801 and 809 is necessary to determine which regulatory controls are appropriate for the new device type class. The devices labeling compliance with parts 801 and 809 is also necessary to determine the devices safety and effectiveness for the purposes of classification.
Comment 54 A comment requests FDA to revise the basis for declining a De Novo request set forth in 860.260c8 this final rule renumbers proposed 860.289b8 as 860.260c8 to specify that a request may only be declined when certain nonclinical studies within the scope of part 58 are not conducted in compliance with those regulations. The commenter asserts that many nonclinical studies are outside the scope of part 58.
Response 54 FDA agrees that a De Novo request may include nonclinical studies that are not subject to part 58, as we explained in Response 38. FDA
would not decline a De Novo request on the basis that a nonclinical study failed to comply with part 58, if that study did not fall within the scope of studies that are subject to part 58. However, FDA is revising 860.260c8 to make this clearer.
Comment 55 A comment requests that FDA revise the paragraph on declining a De Novo request 860.260c10i, this final rule renumbers proposed 860.289b10i as 860.260c10i because the commenter states that failure to follow a protocol is not, per se, a reason to decline a De Novo request.
Response 55 FDA disagrees with the commenters suggestion to revise the provision on declining a De Novo request so that it does not include failure to follow a protocol. The failure to follow a protocol may cause the resulting data to be incomplete, invalid, or otherwise unreliable, and may be a sufficient reason to decline a De Novo request. Protocols typically discuss the objectives, design, methodology, and organization of a clinical or nonclinical study. Significant deviations from a study protocol may lead to a study that, as conducted, does not produce valid scientific evidence. Alternatively, data from a study that was terminated early may not provide sufficient information
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to support a reasonable assurance of safety or effectiveness.
Comment 56 A comment objects to the placement of the paragraph on determining safety and effectiveness as one of the last paragraphs in subpart D
because the commenter states FDA
should do both a classification determination and a determination of the devices safety and effectiveness.
Response 56 FDA does not agree with the comments premise that the location of the paragraph in subpart D
is an indication of the paragraphs importance. The FD&C Act provides that the De Novo process is both a classification and a marketing authorization grant for the particular device section 513f2 of the FD&C
Act. The classification determination and determination of safety and effectiveness are necessary to make a determination regarding the device which is the subject of the De Novo request.
K. Comments and FDA Response on Availability of the De Novo Classification Process for Combination Products Comment 57 A comment requests that FDA clarify that for the summary of risk and mitigations and the risk-benefit discussion required to be submitted in the De Novo request, the summary and the risk-benefit discussion should describe the incremental risk and benefits posed by a combination product because the commenter states the content requirements should reflect that the De Novo classification process is available for combination products.
Response 57 FDA believes that inclusion of this language is unnecessary as we consider section 503g3 of the FD&C Act to be clear regarding its applicability to combination products that include an approved constituent part as defined in section 503g3 of the FD&C Act. In addition, the statute is clear that these considerations apply to such combination products submitted under sections 515, 510k, and 513f2 of the FD&C Act. We do not believe inclusion of this language is necessary to provide further clarity beyond what is stated in the statute. Combination products have distinct premarket review and approvability considerations arising from combining a drug, device, and/or biological product, which retain their regulatory identities when they become constituent parts of combination products. Combination products are also a separate legal category of medical products, distinct from biological products, devices, and drugs. General principles of premarket review and
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