The FDA recently released guidance detailing a new Voluntary Improvement Program that utilizes third-party appraisals to assess and enhance medical device manufacturers’ practices.
The program builds on a previous 2018 pilot and aims to elevate safety, quality, and performance. Participants share appraisal insights with the FDA in exchange for potential benefits like collaborative engagement and favorable regulatory treatment.
With an open enrollment model and tailored continuous improvement framework, the program provides a pathway for manufacturers to demonstrate commitment to best practices.
Here are 10 ways the 2023 VIP differs from the 2018 pilot:
Old: Used CMMI model
New: Uses tailored MDDAP model
The new program employs an appraisal model customized for medical devices rather than the generic CMMI model.
Old: FDA selected participants
New: Open enrollment for eligible sites
Rather than FDA hand-picking participants, the new program allows all eligible manufacturers to enroll.
Old: Required in-person site visit
New: Allows remote appraisal options
Two onsite visits are no longer required, enabling remote appraisal options under the new program.
Old: Assessed 5 process areas
New: Assesses up to 11 practice areas
The program has expanded its appraisal scope from 5 to up to 11 core practice areas.
Old: Submitted reports to FDA
New: Shares appraisal scores with FDA
Instead of detailed reports, the program now provides the FDA with high-level appraisal scores.
Old: FDA observed appraisals
New: FDA does not observe appraisals
The FDA will no longer directly observe third-party appraisals of manufacturers under the new program.
Old: No specific review timelines
New: 10-day review target for 30-day notices
The program sets a 10-day FDA review target for certain regulatory filings like 30-day notices.
Old: No change to inspection planning
New: Considers for inspection planning
FDA may now factor program participation into risk-based inspection planning.
Old: No submission format changes
New: Offers modified submission formats
The program provides submission format modifications to ease regulatory filings for participants.
Old: No formal feedback mechanism
New: Includes quarterly appraiser check-ins
Regular appraiser check-ins give participants feedback under the new program.
