US: FDA has launched a Voluntary Improvement Program to improve medical device quality

On May 5, 2022, US FDA has published and issued a draft guidance, “Promoting Improvements in Medical Devices: Involvement in FDA Activities and Voluntary Improvement Programs.” This blueprint guideline is currently planned for implementation as it is currently open to public comments and as of now, it is not finalized or valid for usage. The purpose of the outline of this guideline upon completion is to explain FDA's policy on the participation in voluntary improvement programs. The Voluntary Improvement Program is a voluntary program that is supported by the Medical Device Innovation Consortium (MDIC) that utilizes third-party evaluations to assess the operational capabilities and performance of medical device manufacturers and improve the quality of medical devices.

FDA's guidance is based on a pilot project conducted by FDA with the Medical Device Innovation Consortium (MDIC) in 2018. This foundational attempt was named as the case of the Quality Independent Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) which is collaborated by FDA and MDIC to inaugurate a charter and governance committee.

Third-party appraisals of medical device manufacturing processes

A quality maturity appraisal's objective is to supply collaborating medical device manufacturing sites with feedback about existing capabilities and potential opportunities for improvement across a broad range of business operations establishing common key quality and performance benchmarks. Through quarterly check-ins crafted to consult and review progress and growth, participating sites and their respective appraisal teams embark on this journey of continual improvement, resulting in enhanced processes and medical device quality, which contributes to positive patient outcomes and increased access for patients.

Cooperating medical device manufacturing facilities profit from VIP assessments since they foster continued growth and organizational innovation. Participating sites promised to cooperate with CDRH and present preliminary information after the appraisal to evaluate their performance on a quarterly basis during the pilot program. The expenditures of the appraisals are supplied by the participating sites.

For this pilot program, FDA acknowledged the prior history of compliance at the site, the firm's dedication to continuous quality improvement, and the information obtained through the appraisal to establish how FDA would prioritize vigilance and prior authorization assessments for participants, in accordance with section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act, which highlights factors that must be considered in evaluating risk-based inspectional preparatory work. Additional evidence from the evaluation process has been included in certain regulatory submissions by FDA, which benefitted the participating sites in resources allocation to innovation and enhancement endeavours.

Qualifying medical device manufacturers for VIP opportunities

FDA will receive some of the findings of VIP manufacturers' procedural appraisals through the appraiser, who will only publicly reveal de-identified, aggregate information. Appraisers would not evaluate compliance with the requirements during site visits since they are not regulatory investigations. No information will be gathered, as well as no rating or accreditation will be issued. Probable perquisite to VIP applicants consists of:

• Opportunity for FDA consideration in risk-based inspection planning

• Opportunity to utilize a 30-day change notices modified submission format for premarket approval application (PMA) and humanitarian device exemption (HDE) for modifications to manufacturing procedures, manufacturing site change supplements and manufacturing modules

Source: Voluntary Medical Device Manufacturing and Product Quality Pilot Program Contact us at info@arqon.com for more information.