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Device Industry Growth Signals FDA Inspection Woes - Performance Plan

This article was originally published in The Gray Sheet

Executive Summary

The inspection rate of once every 3.3 years for high-risk device makers achieved by FDA in FY 1999 stands to erode further, barring additional future funding, the agency acknowledges in its December "Performance Plan Summary" submitted to Congress.

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MDMA Identifies Top FDA, HCFA Priorities In 2001 Public Policy Agenda

The Medical Device Manufacturers Association's 2001 public policy agenda spotlights the debate over the claims substantiation guidance, which is expected to be released this year.

FDAMA compliance

Agency inspections of domestic medical device firms average one inspection per 3.3 years, according to FDA's "statutory inventory" rate for fiscal 1999. The FDA Modernization Act of 1997, by contrast, requires such inspections at least every two years. Despite the discrepancy, FDA "believes it most rationally uses its limited inspection resources by focusing on issues that pose the most serious public health risks," particularly through industry education and outreach programs, the agency says in its report on 1999 FDAMA accomplishments, released Oct. 11. The agency acknowledges it is "unable to fulfill its mandated responsibilities in two areas: the timely review of new regulated products...and inspections of drug and medical device establishments"

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