Medical Device Daily Washington Editor

While most folks who work at FDA would rather not spend much time under the blaring political spotlight, the agency is usually the subject of much scrutiny, and a Jan. 29 report on FDA device inspections, authored by the Government Accountability Office (GAO), disclosed that the agency is having a brutal time keeping up with inspections, likely turning up the heat further on the already beleaguered agency.

The GAO report, signed by Marcia Crosse, director of healthcare for GAO, was delivered to the Oversight and Investigations Committee of the House Energy and Commerce Committee earlier this week (Medical Device Daily, Jan. 30, 2008), and Crosse’s testimony indicates that GAO is not optimistic about the third-party inspection initiatives now underway.

The report said that the agency typically inspects domestic class III device makers only every three years rather than every two years as is required, and U.S. makers of class II devices only every five years rather than every three years.

Foreign makers of class II devices had seen an FDA investigator only every 27 years on average, the report noted, and overseas companies making class III devices saw an FDA investigator only every six years.

GAO said that the third-party inspection program has been of limited value, with “the small number of inspections completed” raising “questions about the practicality and cost effectiveness” of adding more third-party capacity.

GAO has addressed the third-party inspection program in previous reports to Congress. FDA was statutorily limited to contracting with 15 organizations to conduct inspections (MDD, Jan. 25, 2007) under the Accredited Persons Inspection Program (APIP), but even though the limit was raised, most of the companies that applied never got around to obtaining full certification from FDA to conduct the inspections.

However, the GAO report notes that as of Jan. 11, FDA had accredited 16 such organizations and of greater importance was the fact that “individuals from eight of these organizations had completed FDA’s training and had been cleared to conduct inspections.”

FDA and these inspectors had conducted 44 total joint training inspections, but “fewer manufacturers volunteered to host training inspections than have been needed.” The report also noted that FDA’s short scheduling for inspections have left third-party companies out “because they had prior commitments.”

The FDA Amendments Act of 2007, the report notes, eliminated the requirement that FDA periodically inspect foreign device manufacturing plants, which might provide some relief to FDA’s inspection work plan.

FDA inked a cooperative agreement with Health Canada in 2006 for joint inspections of device makers located in either nation that would satisfy the requirements of both countries, but GAO expressed skepticism that the PMAP (Pilot Multi-Purpose Audit Program) audit agreement would make much difference in part because it largely replicates the broader APIP program, which is designed in part to help firms cover the inspectional requirements of non-U.S. regulatory bodies.

The sheer volume of device manufacturing facilities FDA is tasked with inspecting is impressive. According to GAO, “more than 23,600 establishments that manufacture medical devices were registered as of Sept. 2007,” with about half of them making class II or class III devices. The U.S. is home to roughly 5,600 of these, but China accounts for another 675 and Germany 581.

Language barriers are a problem for FDA investigators. According to GAO, FDA has not been in a position to provide translators, relying instead on “an English-speaking representative of the foreign establishment being inspected, rather than an independent translator.” The report also noted that the U.S. Department of State has not provided translators, either.

FDA has relied largely on volunteers to handle the overseas inspections, but the agency indicated “it is difficult to recruit investigators to voluntarily travel to certain countries.” FDA field investigators must have three years of experience examining domestic plants before they can inspect overseas plants, which reduces the body of eligible investigators.

FDA also has not placed as high a priority on pre-approval inspections as might be thought. GAO said that “relatively few” premarket inspections take place, in part because devices cleared under the 510(k) path do not trigger premarket inspections. “Therefore, FDA focuses its resources on post-market inspections,” which accounted for 95% of the almost 9,000 domestic inspections conducted between 2002 and 2007. The numbers are similar for foreign audits, with 89% of the 1,481 audits conducted on a post-market basis.

Predictably, FDA’s information technology base drew no raves. FDA’s legacy system for tracking device manufacturing plants, the Device Registration and Listing System (DRLS) had a list of roughly 10,600 domestic and foreign plants, but this registry includes plants that are either not making medical devices at all or are not shipping the devices they make to the U.S.

The Operational and Administrative System for Import Support (OASIS) is “not intended to provide a count of establishments, but lists the source of imported devices. Apparently the U.S. Customs Service is responsible for some of the information in OASIS, and duplication is the result of “inaccurate data entry by customs brokers at the border.”

As a result, FDA employees are stuck with the task of making manual comparisons between these two databases because “the databases cannot exchange information ... electronically.”

Mark Leahy, executive director of the Medical Device Manufacturers Association (MDMA; Washington), told Medical Device Daily that the association’s members “continue to support additional congressional-appropriate funds to assist FDA in meeting the many challenges it faces.” Leahy said the device industry “has seen a significant increase in user fees over the past six years which cannot be sustained over the long term” and called on Congress and the White House “to fund this critical agency appropriately.”