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FDA MDUFMA Interpretation Stalls Third-Party Program At The Gate – NEMA

This article was originally published in The Gray Sheet

Executive Summary

Third-party inspection standards outlined in an April 1FDA draft guidance on MDUFMA implementation could limit the ability of companies to hire EU-based third-party auditors, according to the National Electrical Manufacturers Association

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Third-party inspection talks

NEMA expects to meet with FDA within the next two weeks to continue discussions on "flexible" approaches to the MDUFMA-mandated program, such as multiple-stage inspections conducted within a two-year period and bundled appraisals. National Electrical Manufacturers Association reps met with FDA Assistant Commissioner for Regulatory Affairs Steve Niedelman in July to confer about possible solutions, following the trade group's May 23 comments on the agency's program guidance (1"The Gray Sheet" June 2, 2003, p. 18). FDA received 23 applications for accreditation status by the Aug. 25 deadline (2"The Gray Sheet" Sept. 1, 2003, p. 14)...

Third-party inspection talks

NEMA expects to meet with FDA within the next two weeks to continue discussions on "flexible" approaches to the MDUFMA-mandated program, such as multiple-stage inspections conducted within a two-year period and bundled appraisals. National Electrical Manufacturers Association reps met with FDA Assistant Commissioner for Regulatory Affairs Steve Niedelman in July to confer about possible solutions, following the trade group's May 23 comments on the agency's program guidance (1"The Gray Sheet" June 2, 2003, p. 18). FDA received 23 applications for accreditation status by the Aug. 25 deadline (2"The Gray Sheet" Sept. 1, 2003, p. 14)...

Third-Party Inspections Hit Potential Legal Snag: Will MRA Save The Day?

Proactive implementation of third-party inspections authorized by MDUFMA is needed to obtain a simpler version of the program through legislation, CDRH Director David Feigal said during a Nov. 21 AdvaMed seminar on the Medical Device User Fee & Modernization Act

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