Lack of Participation Threatens Inspection Program

The future of the FDA’s third-party inspection program may be in jeopardy because medical device manufacturers are hesitant to participate, an expert says.

“There has been a steady increase in inspections, but overall, it has to be said that the program is not utilized the way we would like to see it,” Gregor Dzialas, Accredited Persons (AP) program manager and certification officer for TUV Rheinland, said at an FDAnews audioconference.

“A lot of resources have been put into this program. If we don’t see this trend continue and maybe even speed up, the validity of the program will be challenged by the FDA and also by APs in order to justify the resource,” he continued.

The AP program, open to registered domestic and foreign device firms with Class II and III devices, is voluntary and allows companies to have quality system inspections conducted by approved third parties instead of FDA investigators. The program is intended to reduce inspection-related manufacturing interruptions and result in cost savings for devicemakers.

Challenges have included the limited availability of qualified auditors, restrictive eligibility requirements and manufacturers’ fear of inviting an FDA inspection. Dzialas said these problems are being resolved as the FDA has approved more qualified auditors and revised eligibility requirements to make it easier for firms to participate.