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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations controls used by the manufacturer to ensure consistent levels of drug coating and drug release batch-to-batch. Such information would be critical to FDA in its De Novo determination because assessment of the sampling methodology and laboratory controls at the manufacturing facility would aid in FDAs determination that the product has consistent levels of drug coating and drug release batch-to-batch. This information would enable FDA to determine whether the proposed special controls are sufficient to reasonably assure safety and effectiveness or if additional controls are needed.
In another example, FDA may receive a De Novo request for a device that is provided sterile using a novel sterilization method for which there is little or no published information and limited or no history of FDA evaluation of sterilization development and/or validation data. Probable risks associated with inadequate sterilization may include risk of infection or contamination. An inspection of the facility where the device is sterilized would be critical to determining if special controls regarding sterilization validation are sufficient to mitigate the devices probable risks, verify that the novel sterilization method can feasibly be carried out, and determine if additional controls are needed to mitigate the risks associated with inadequate sterilization to reasonably assure the devices safety.
One commenter objected to inspections used to assess whether QSRs are adequate to ensure that critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device are controlled on the grounds that such inspections require either a warrant or specific statutory authorization under the Constitution. Section 704a1 of the FD&C Act grants FDA authority to enter and inspect any factory, warehouse, or establishment in which food, drugs, or devices are manufactured, processed, packed, or held for the introduction into interstate commerce or after such introduction. 21 U.S.C. 374. In addition, FDA intends to undertake inspections only in limited circumstances when the inspection is to help determine whether to grant a De Novo request from a firm and determine whether the proposed special controls are sufficient to reasonably assure safety and effectiveness or if additional controls are needed under section 513f2 of the FD&C Act.

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F. Comments and FDA Response on Definitions Comment 15 A comment proposed several changes to the Supplemental data sheet definition because not all implanted devices are class III, and another comment recommended changes to Form FDA 3429 General Device Classification Questionnaire.
Response 15 These comments are moot because, in a separate rulemaking see 83 FR 64443 at 64454 through 64456, December 17, 2018, effective March 18, 2019, the definitions for the terms Supplemental data sheet and Classification questionnaire were removed from 860.3 and the prior requirements to provide Form FDA 3427
Supplemental Data Sheet and Form FDA 3429 General Device Classification Questionnaire were removed from 860.84 and 860.123.
Comment 16 A comment requests that FDA keep the individual paragraph designations in the definitions section 860.3 because the commenter states it is helpful to industry to be able to cite a specific term by paragraph designation.
Response 16 FDA disagrees with this comment. FDA believes it would be easier for industry to locate definitions listed alphabetically. FDA has taken a similar approach in its labeling and unique device identification regulations see 21 CFR 801.3 and 830.3. FDA
further believes that it is not difficult to cite to alphabetical definitions within 860.3.
G. Comments and FDA Response on De Novo Request Format Comment 17 A comment asks FDA
to revise the proposed De Novo request format requirements to clarify that the application can be a single version in electronic format, conforming it to FDAs proposed rule, Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format 83 FR
46444, September 13, 2018.
Response 17 FDA agrees that a De Novo request may be submitted as a single version in electronic format, which is currently eCopy and, in the future, may be a different electronic format. De Novo requests currently must be submitted as a single eCopy, in accordance with section 745Ab1 of the FD&C Act 21 U.S.C. 379k1b1
and FDAs guidance, eCopy Program for Medical Device Submissions, issued April 27, 2020 Ref. 8. Section 745Ab3 of the FD&C Act requires the presubmission and submission types enumerated in section 745Ab1

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including De Novo requests, any supplements to such presubmissions or submissions for devices, and any appeals of action taken with respect to such presubmissions or submissions, including devices under the Public Health Service Act, to be submitted solely in electronic format as specified by FDA in guidance. Once FDA issues guidance under section 745Ab3 of the FD&C Act, the Agency can require De Novo request submissions in electronic formats other than eCopy. We are revising paragraph 860.210a this final rule renumbers proposed 860.223a as 860.210a to require submission of a De Novo request as a single version in electronic format.
Comment 18 A commenter states it is overly prescriptive to require a specific format for a De Novo request.
Response 18 We do not agree that the format FDA is requiring is overly prescriptive. Section 860.210 this final rule renumbers proposed 860.223 as 860.210, the format section, requires that the De Novo request be signed by the requester or an authorized representative, be designated as a De Novo request, and be written or translated into English. FDA believes it is easier for FDA reviewers to find required information if the De Novo request information is provided in a specific format, thereby facilitating more efficient review and processing of the request.
Comment 19 Because a De Novo request may contain only one volume, a comment asks FDA to revise the De Novo request format paragraph to qualify that the table of contents of a De Novo request reference a volume number only if the De Novo request contains more than one volume.
Response 19 FDA agrees that it is unnecessary to cite the volume if the De Novo request does not contain more than one volume. We are revising paragraph 860.220a1 this final rule renumbers proposed 860.234a1 as 860.220a1 accordingly.
H. Comments and FDA Response on De Novo Request Content Comment 20 Some comments request FDA to revise the Device description provision at 860.220a6ii this final rule renumbers proposed 860.234a6ii as 860.220a6ii because the commenters state some of the terminology is more typically used to describe drugs than devices. The commenters suggest that component is more applicable to devices than ingredient, and that some components may not be functional but may still be important to a De Novo
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