Third-party inspection talks
This article was originally published in The Gray Sheet
Executive Summary
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)...