Third-Party Inspection Program Off to Shaky Start

Medical Device & Diagnostic Industry Magazine
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Originally Published MDDI January 2006

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Industry representatives and others expressed doubts about the future of the third-party inspection program at November's MDUFMA stakeholders meeting.

It has been more than two years since CDRH identified 15 accredited persons (APs) as eligible to perform third-party inspections. But to date, only five have completed the training. The main problem has been convincing device firms to schedule training audits for the APs. They need to perform three such audits with FDA before they can audit firms on their own.

And even if the program, which was codified in MDUFMA, does succeed, it is expected to have low participation in its early years, as the third-party 510(k) review program did.

“We are concerned that the process for certifying APs has been slow, arduous, and expensive,” said Bob Britain, top medical official for the National Electrical Manufacturers Association. “The current program is cumbersome and not user-friendly.” One drawback is that firms must change APs after a certain number of inspections, which may limit participation, Britain explained. “The bright side is that many of us are optimistic. We want to make it work, and we need FDA to work with us to make it least burdensome, efficient, and of reasonable cost.”

Much of the program's value lies in its ability to be combined with third-party inspections from other nations, Britain said. That means inspection requirements for markets around the globe could be satisfied with a single audit. But if it never catches on in the United States, the concept will die globally.

Lindsey Wade, a policy associate for the advocacy group National Research Center for Women and Families, believes the program should be scuttled because it forces APs to have a conflict of interest.

“There is no firewall between them and the company,” Wade said. “They curry favor by taking on a consulting role when they do their inspections. A consultant–end-user relationship is different from an inspector-inspectee one. Manufacturers are supplying APs with testimonials to increase their future business. This sort of communication reduces the AP's ability to be unbiased.” Even if scrapping third-party inspections made audits less frequent, that would be better for the public health than more-frequent inspections conducted by third parties, she said.

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