Insights

18 September 2023

10 things to know about the FDA's new Voluntary Improvement Program

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.

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.

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