Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-23716 · Docket No. FDA-2024-D-4409

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway.” The device-specific guidance identified in this notice was developed in accordance with the finalized guidance entitled “Safety and Performance Based Pathway.” This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

Dates

The announcement of the guidance is published in the Federal Register on October 15, 2024.

Supplementary Information

I. Background The Agency is announcing the availability of the final guidance document “Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway.” This device-specific guidance document provides performance criteria for premarket notification (510(k)) submissions to support the optional Safety and Performance Based Pathway, as described in the guidance entitled “Safety and Performance Based Pathway.” 1 As described in that guidance, substantial equivalence is rooted in comparisons between new devices and predicate devices. However, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ) does not preclude FDA from using performance criteria to facilitate this comparison. If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device(s). Under this optional Safety and Performance Based Pathway, a submitter of an endosseous implant and endosseous implant abutment device could satisfy the requirement to compare its device with a legally marketed device by, among other things, independently demonstrating that the device's performance meets performance criteria as established in the relevant above-listed guidance rather than using direct predicate comparison testing for some of the performance characteristics. 1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway . This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this policy is being implemented immediately without prior comment, it remains subject to comment in accordance with FDA's good guidance practices regulation (21 CFR 10.115(g)(3)(D)). FDA will consider all comments received and revise the guidance document as appropriate. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway. It does not establish any rights for any person and is 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 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 “Endosseous Dental Implants and Endosseous Dental Implant Abutments—Performance Criteria for Safety and Performance Based Pathway” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00021017 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 (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part; guidance; or FDA form Topic OMB Control No. 807, subpart E Premarket notification 0910-0120 “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 Dated: October 4, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024-23716 Filed 10-11-24; 8:45 am]