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lotter on DSK11XQN23PROD with RULES1

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations De Novo request is based on complete and quality information and minimize review staffs need to request additional information. We believe the term should reasonably be known appropriately captures the intent of these requirements.
Comment 23 A comment requests that FDA provide more flexibility in the standard for valid scientific evidence for De Novo devices as a way to address lower risk devices, rather than requiring only less-detailed summary information for some components of a complete De Novo request.
Response 23 FDA disagrees with the comment. As in other device classification processes, FDA relies upon valid scientific evidence in determining the safety and effectiveness of a device that is the subject of a De Novo request 860.260e this final rule renumbers proposed 860.289d as 860.260e. This is unchanged by the requirement to provide summaries of certain information as part of a De Novo request. In addition, the required content of a De Novo request must include, in addition to such summaries, technical sections containing nonclinical study results, software information and testing, and clinical investigation results with sufficient detail to allow FDA to make a determination on the De Novo request.
Regarding the commenters request for flexibility in the standard for valid scientific evidence, FDA does not believe any change is necessary. FDAs regulatory definition of valid scientific evidence already makes clear that the evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use 860.7c2.
FDA has also issued guidance explaining its approach to making benefit-risk determinations in the context of De Novo requests, which is a flexible, patient-centric approach tailored to the type and intended use of the device. See our guidances Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Ref. 3 and Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Ref.
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Comment 24 A commenter states FDA should focus on device design to improve device safety. The same commenter asserts that all premarket applications PMA, 510k, and De Novo
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requests should include a design and development plan, design input, output, design reviews, verification, validation, transfer, and all design changes.
Response 24 FDA agrees that device design is important to device safety.
Manufacturers are already required under part 820 QSR to focus on device design 820.30, Design controls.
Additionally, FDA may require additional verification or validation information for specific design features or inspect relevant facilities, where appropriate 860.240, this final rule renumbers proposed 860.256 as 860.240.
Comment 25 Because a commenter notes that manufacturer is used elsewhere in the proposed rule and because some commenters state that many companies no longer use Fax machines, the comments request that FDA revise the Administrative information provision of the De Novo request content section to add a reference to manufacturer, in addition to owners and operators, and to remove the reference to Fax machines from 860.220a2 this final rule renumbers proposed 860.234a2 as 860.220a2.
Response 25 FDA agrees to remove the reference to Fax machines and is revising paragraph 860.220a2 this final rule renumbers proposed 860.234a2 as 860.220a2
accordingly. However, we do not agree that it is necessary to add a reference to manufacturer in this provision. In the final rule, 860.220a2 requires that the De Novo request include the establishment registration number of the owner or operator submitting the De Novo request, if applicable, because certain owners or operators, as defined in 21 CFR 807.3f, are the entities required to register and submit listing information under 21 CFR part 807. Use of the terms owner and operator in 860.220a2 does not mean that a device manufacturer is unable to submit a De Novo request. The registration and listing requirements apply to owners or operators of establishments who are engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use, unless they are exempt under 510g of the FD&C Act or FDA regulations see 21 CFR 807.20.
Comment 26 A comment requests FDA revise the indications for use paragraph 860.220a5, this final rule renumbers the proposed 860.234a5 as 860.220a5 in the De Novo request content section to include references to intended use and the meaning of that term for the purpose
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of determining substantial equivalence because intended use will be relevant to 510k submissions made after FDA
grants a De Novo request. The commenter also suggests the revisions would align more closely with the PMA
requirements in 814.20b3.
Response 26 FDA does not agree with this comment and believes that the indications for use requirement is aligned with 814.20b3i and the definitions in Appendix D of FDAs guidance, The 510k Program:
Evaluating Substantial Equivalence in Premarket Notifications 510k Ref.
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Comment 27 A few commenters state it is unnecessary and places a potentially unrealistic burden on the De Novo requester to provide a complete device description; the comments request FDA require a device description.
Response 27 FDA disagrees with these comments and is retaining the word complete in 860.220a6 this final rule renumbers the proposed 860.234a6 as 860.220a6. The word complete is appropriate in this context and not overly burdensome.
FDA does not expect an excessively detailed description of the device, but there must be sufficient detail to describe the aspects of the device that could affect safety or effectiveness. A
complete device description is necessary for FDA to classify a device.
Comment 28 Comments on the requirement to describe alternative practices 860.220a7, this final rule renumbers proposed 860.234a7 as 860.220a7 either support the requirement as facilitating classification and improving transparency, or request revisions to reduce the burden of describing known or reasonably known alternative practices and procedures.
The comments suggest revising the provision to instead ask for a summary related to the standard of care for a disease or condition for which the device is indicated as it bears on the devices proposed classification or assessment of probable benefits and risks.
Response 28 FDA disagrees with the comments to limit the description of alternative practices. We do not believe this requirement requires extensive unnecessary efforts, as some of the commenters suggest. As explained in the proposed rule, this requirement is intended to capture alternative biologic, device, or drug practices or procedures.
An understanding of available alternative practices or procedures that are used to diagnose, treat, prevent, cure, or mitigate the disease or condition for which the device is
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