Medical Device Daily Washington Editor

WASHINGTON — The FDA has long since abandoned any pretense that it can maintain the inspection regime of device manufacturers on a biennial basis, opting instead for a risk-based evaluation of the industry’s regulatory hot spots.

For better or for worse, five years or more often pass between inspections, a state of affairs that has existed for more than a decade, and which gave impetus to the contract inspection provisions of the Medical Device User Fee Modernization Act (MDUFMA) of 2002.

However, despite intense interest in third-party inspections dating back to the late 1990s, industry has not embraced this mechanism.

In a recent report to both houses of Congress, the Government Accountability Office (GAO) details both the statutory features that have impeded the use of third-party inspectors, as well as some of the inevitable barriers arising from the agency’s need to maintain jurisdiction over device manufacturing plants.

The GAO report notes that MDUFMA limited the number of third-party inspection entities to 15 in the first year after the agency published the criteria for accreditation. Those criteria include demonstration of competence as well as demonstration of lack of conflict of interest.

According to the GAO, the agency accredited the maximum of 15 organizations after taking in 23 applications in that first year. Of that number, two failed to complete the paperwork appropriately and another two could not satisfy the FDA that they were competent. The remaining 19 were sorted by demonstrated competence, leaving the maximum of 15. However, only two firms have applied since, only one of which made the grade.

Despite having gone to all the trouble to qualify, interest on the part of those existing third-party inspectors has apparently waned.

“As of Oct. 31, 2006, individuals from seven of the 16 accredited organizations had completed all training requirements,” but the remaining nine currently have no inspectors who are certified to handle FDA inspections.

The training requirements involve three inspection episodes for both FDA field personnel and the third-party inspector.

In the first episode, the couple are both present, with the novice acting “primarily as an observer.” The FDAer can help the trainee out on the second inspection, but can only observe on the third training inspection.

The amount of preparation and training forces third parties to charge a substantial sum for their work, which cannot whet the appetites of an industry already at loggerheads with Congress over user fees.

The GAO document indicates that outside of 36 training inspections, contract inspectors have conducted only two inspections, one of which was of a plant outside the U.S. The domestic plant hired the inspector for obtaining clearance by the FDA, Health Canada and the European Union.

Health Canada and the FDA are currently working on a pilot program to allow either nation’s inspectors to qualify a plant for both nations’ regulatory bodies, but the effort commenced only last September.

One of the drawbacks to the program is the universal hang-up with most things — cost. The FDA charges no fee for inspections, but third-party inspectors obviously must charge some sort of fee.

Another barrier postulated by the report is that “manufacturers that already contract with a specific accredited organization to conduct inspections to meet the requirements of other countries might defer participation until FDA has cleared that organization to conduct independent inspections.”

Companies that want to hire a third party have to obtain the agency’s approval and must also have earned a rating no stronger than “no action indicated” or “voluntary action indicated” in the previous FDA inspection. Under MDUFMA, any company that wants to hire a third party for a second consecutive inspection within four years has to obtain a waiver from the agency.

This feature of the statute ran afoul of the fact that accredited inspection companies sometimes take more than one visit to complete an inspection, and if the accredited company requires two years to complete a first full inspection, the requester could not obtain a second full inspection from that third party until four years after the completion of the inspection cycle — rather than after the commencement of that cycle.

Given the agency’s mandate to inspect each plant every two years, this predicament serves to further blunt any interest in use of third-party inspection companies.

The GAO stated that the FDA is aware of this trap door and “is considering a proposal for an additional technical correction to address it.” But as might be inferred by the lack of interest in third-party inspections in general, the statutory problem has not resulted in any refusals for third-party inspection applications. Whether it has suppressed interest on the part of industry is not made clear.

According to the GAO report, the agency and industry “told us that manufacturers would prefer to reduce the number of inspections . . . by having a single inspection” that covers domestic and foreign regulators, but those respective requirements “are similar but not identical.” Hence, a multiple-requirement inspection is liable to take up more time than an inspection for a single regulatory body, but less time than multiple inspections.

Still, firms are wary of claims that a third party “can cover multiple requirements in a single inspection.”

The GAO report indicates that third-party inspectors have not done themselves any service, apparently telling their clients that rather than inspect for two regulatory regimes in one shot, they would prefer to “instead conduct two separate inspections.”

Finally, many firms are apparently inclined to hedge their bets on inspection frequency.

The report states that firms who talked to the GAO indicated that they wonder about the benefit of “committing to an inspection to assess compliance . . . in the near future, even though it is possible that FDA would not inspect them in the next five to six years” with our without the third-party audit.

Companies are also concerned that anything other than a squeaky-clean inspection might prompt the agency to conduct an inspection of its own and/or engage in regulatory action, such as penning a warning letter.

Given the possibility that the agency might not have inspected that plant until much later, many companies find it difficult to justify paying for that type of inspection.