The Draft Guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” was published today in the Federal Register for a 60-day public commenting period.
“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.”
You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions about this document, contact Compliance and Quality Staff within OPEQ:Office of Product Evaluation and Quality/IO:Immediate Office at CaseforQuality@fda.hhs.gov.