Combined Inspections:FDA’s Third-Party Carrot

Originally Published MDDI December 2003

EDITOR'S PAGE

Combined Inspections: FDA's Third-Party Carrot

To ensure the success of its voluntary third-party inspection program, FDA is counting on concurrent inspections to be enough incentive for industry.

FDA readily admits it can no longer keep up with inspections. So, with a third-party inspection program in place, FDA is pulling out all the stops to encourage industry to actually use it.

Under the program, device manufacturers can now arrange for FDA and other conformity inspections to occur at the same time. That is, of course, provided that the inspecting firm—one of the 15 newly appointed Accredited Persons (APs)—is also a conformity assessment body.

FDA is touting this benefit as a really big carrot for industry. The third-party inspectors can perform audits and inspections to the requirements for multiple nations—something FDA can't do. Instead of scheduling multiple audits to show compliance with nearly identical requirements, manufacturers could reduce the number of inspections by combining them.

CDRH director David Feigal Jr. says that such incentives should encourage industry to use the program, which he calls industry's best avenue to “eventually developing multipurpose inspections.” 

“It is highly unlikely that FDA will ever have the resources to allow our inspectors to grant a CE mark, but it may be possible for a third-party
inspector to do that,” Feigal noted at the Regulatory Affairs Professionals Society (RAPS) conference in Baltimore in October. Allowing third-party inspections was “the most important legislative change for Congress to make” last year, Feigal said at an AdvaMed meeting last March.

Feigal acknowledges that the program has limitations. Under the program, FDA must conduct every third inspection, and the agency must conduct all preapproval inspections. An added hurdle requires that manufacturers show that the law in a country where the device will be marketed recognizes FDA inspections. No country currently has such a law, which means that FDA must now figure out how to address this legislated requirement that asks manufacturers to do the impossible.

The good news is that FDA is actively tackling these limitations in its industry presentations and guidance documents. FDA wants to ensure that the program can get off the ground. If enough device manufacturers use the new third-party program, it would free FDA to allocate its limited resources more strategically, including increasing the number of facilities it inspects.

FDA is required by law to conduct routine inspections every two years. However, for device manufacturers of lower-risk technologies, the agency has been able to perform such inspections only every five to seven years, according to AdvaMed.

Feigal also says it would be nice to build the program to the point where FDA could even allow third-party preapproval inspections. He is calling on industry to take advantage of the benefits of the third-party program. The sooner that happens, he says, the sooner FDA will have the confidence necessary to allow APs to conduct preapproval inspections as well.

Now it is up to industry to determine whether the carrots being offered are big enough. If so, industry needs to state loud and clear to the APs that the incentive of grouped inspections would make the program worth using. The time and money saved could be substantial.

Much of the onus, however, falls on the newly named APs to develop systems for concurrent inspections. It may take some time for them to mesh existing assessment programs with FDA requirements. The inspection program is voluntary, and its success rests squarely on the shoulders of the medical device industry.

The Editors

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