Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2023-20016 · Docket No. FDA-2022-D-0109

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program.” FDA is issuing this guidance to describe its policy regarding FDA's participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer's practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA's 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.

Dates

The announcement of the guidance is published in the Federal Register on September 15, 2023.

Supplementary Information

I. Background As part of the Center for Devices and Radiological Health's (CDRH's) 2016-2017 strategic priority to “Promote a Culture of Quality and Organizational Excellence,” CDRH envisions a future where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety. Among its other regulatory activities, FDA evaluates manufacturers' compliance with regulations governing the design and production of devices. Compliance with the “Quality System Regulation,” 21 CFR part 820, is a baseline requirement for medical device manufacturing firms. 1 1 On February 23, 2022, FDA proposed to amend the device QS regulation, 21 CFR part 820, to align more closely with international consensus standards for devices (87 FR 10119; available at https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments ). Specifically, FDA proposed to withdraw the majority of the current requirements in part 820 and instead incorporate by reference the 2016 edition of the International Organization for Standardization (ISO) 13485, Medical devices—Quality management systems for regulatory purposes, in part 820. As stated in that proposed rule, the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current part 820, providing a similar level of assurance in a firm's quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. FDA intends to finalize this proposed rule expeditiously. When the final rule takes effect, FDA will also update the references to provisions in 21 CFR part 820 in this guidance to be consistent with that rule. In an effort to elevate and enhance manufacturing practices and behaviors through which quality and safety of medical devices can be improved, FDA has collaborated with various stakeholders, brought together through the MDIC public-private partnership, to develop the CfQ Pilot Program. FDA announced the voluntary CfQ Pilot Program in the Federal Register on December 28, 2017 (82 FR 61575). As in the CfQ Pilot Program, the VIP oversees third-party appraisers who evaluate voluntary industry participants, and the VIP assesses the capability and performance of key business processes using a series of integrated best practices. Those practices are detailed in the Information Systems Audit and Control Association Capability Maturity Model Integration (CMMI) system. CMMI provides a roadmap that guides improvement toward disciplined and consistent processes for achieving key business objectives, including quality and performance. The VIP uses a version of the CMMI appraisal appropriate for the medical device industry. This appraisal tool is referred to as the Medical Device Discovery Appraisal Program (MDDAP) model. The baseline appraisal using the MDDAP model covers 11 practices areas, such as Governance, Implementation Infrastructure, and Managing Performance and Measurement. Subsequent appraisals may include an alternate list of practice areas compared to the baseline set. As part of the VIP, and as in the CfQ Pilot Program, the program provides firms and FDA with information about the firm's capability and performance for activities covered in the third-party appraisal. Details and results from the 2018 CfQ Pilot Program are outlined in MDIC's Case for Quality Pilot Report, available at https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program. This voluntary program is currently only available to eligible manufacturers of medical devices regulated by CDRH and whose marketing applications are reviewed under the applicable provisions of the Federal Food, Drug, and Cosmetic Act (including under sections 510(k), 513, 515, and 520) (21 U.S.C. 360(k), 360c, 360e, and 360j). A notice of availability of the draft guidance appeared in the Federal Register of May 6, 2022 (87 FR 27165). FDA considered comments received and revised the guidance as appropriate in response to the comments, including clarifying what participants must demonstrate to benefit from the opportunities offered by VIP, explaining that program participation is not a substitute for an FDA inspection, and providing further detail regarding the role of FDA in VIP. 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 Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program. 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00020039 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 guidance also refers to previously approved FDA collections of information which are also subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table: 21 CFR part; Guidance; or FDA form Topic OMB control No. “Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program” Voluntary Improvement Program (VIP) 0910-0922 807, subpart E Premarket notification 0910-0120 7 Recalls 0910-0432 814, subparts A through E Premarket approval 0910-0231 814, subpart H Humanitarian Device Exemption 0910-0332 860, subpart D De Novo classification process 0910-0844 803 Medical Device Reporting 0910-0437 806 Medical Devices; Reports of Corrections and Removals 0910-0359 820 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation 0910-0073 807, subparts A through D Medical Device Registration and Listing 0910-0625 Dated: September 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-20016 Filed 9-14-23; 8:45 am]