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# AdvaMed Recommends ‘Appraisal Program’ Improvements
- URL: https://www.fdaweb.com/advamed-recommends-appraisal-program-improvements/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140327

AdvaMed says FDA’s voluntary medical device manufacturing and product quality program (appraisal program) reflects “the agency’s use of innovative strategies to collaborate with stakeholders to improve medical device design and manufacturing quality and, by extension, public health outcomes…. AdvaMed supports the appraisal program and hopes it will succeed in its pilot stage and transition to a fully-deployed program. To that end, AdvaMed has identified several areas where the appraisal program might be improved.”

The association’s comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-4180-0005&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) makes these recommendations for greater transparency, specificity, consistency, and certainty: 

- provide greater transparency about the appraisal process;
- provide specific, transparent information about appraisal program costs;
- further develop and communicate the benefits of appraisal program participation;
- provide greater clarity about how FDA quality and compliance initiatives overlap;
- develop and use a common vocabulary to describe the appraisal program;
- develop and share consistent metrics that show the performance of participants in the appraisal program and the program’s overall success;
- expand the appraisal program to recruit participants who use 510(k) submissions to bring products to market;
- open the appraisal program to participants with Official Action Indicated inspection results and equivalent MDSAP (Medical Device Single Audit Program) nonconformity findings;
- assure accurate and consistent representations by appraisal program participants;
- provide a uniform set of evaluative factors for accurate benchmarking;
- develop an adverse event response plan; and
- develop a plan to transition the appraisal program to a fully-deployed program.