Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2023-20029 · Docket No. FDA-2019-N-4060

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled “Medical Devices with Indications Associated with Weight Loss—Clinical Study and Benefit-Risk Considerations” and “Medical Devices with Indications Associated with Weight Loss—Non-Clinical Recommendations.” These draft guidance documents provide recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how FDA considers the benefit-risk analysis to support such indications, and provide recommendations for the non-clinical testing to support premarket submissions for these medical devices. These draft guidances are not final nor are they for implementation at this time.

Dates

Submit either electronic or written comments on the draft guidance by November 14, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background These draft guidance documents provide recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how FDA considers the benefit-risk analysis to support such indications, and provide recommendations for non-clinical testing to support premarket submissions for these medical devices. These devices may be indicated for weight loss, weight reduction, weight management, or obesity treatment in patients who are overweight or have obesity. The recommendations and considerations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. Prior to drafting these guidances, FDA requested public comment on a concept for balancing the benefit of weight loss with the risks of adverse events in a discussion paper (September 2019, Docket No. FDA-2019-N-4060). FDA considered public comments and incorporated the feedback as appropriate in developing the draft guidance, “Medical Devices with Indications Associated with Weight Loss—Clinical Study and Benefit-Risk Considerations.” These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidance documents, when finalized, will represent the current thinking of FDA on “Medical Devices with Indications Associated with Weight Loss—Clinical Study and Benefit-Risk Considerations” and “Medical Devices with Indications Associated with Weight Loss—Non-Clinical Recommendations.” They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Medical Devices with Indications Associated with Weight Loss—Clinical Study and Benefit-Risk Considerations (document number GUI00021016)” or “Medical Devices with Indications Associated with Weight Loss—Non-Clinical Recommendations (document number GUI00019046)” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic OMB control No. 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 812 Investigational Device Exemption 0910-0078 860, subpart D De Novo classification process 0910-0844 “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” Q-Submissions and Early Payor Feedback Request Programs for Medical Devices 0910-0756 800, 801, 809, and 830 Medical Device Labeling Regulations; Unique Device Identification 0910-0485 820 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910-0073 50, 56 Protection of Human Subjects: Informed Consent; Institutional Review Boards 0910-0130 58 Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies 0910-0119 Dated: September 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-20029 Filed 9-14-23; 8:45 am]