Several device industry representatives told lawmakers on Capitol Hill May 14 that additional FDA user fees and expansion of pre-approval inspection authority to include less risky, Class II devices should not be part of a proposed bill making its way through Congress. They got support from the Republican members of the panel.

Democrats on the House Energy and Commerce Health Subcommittee held the hearing to get feedback on the device- and cosmetic-focused sections of the draft FDA Globalization Act, intended to strengthen FDA's oversight of imported products. The draft was released for public discussion in April but has not yet been formally introduced.

The draft bill is broad, but focuses on food and drug import oversight.

The device sections would expand FDA inspection authorities and create a new industry user fee to help pay for the inspections. Specifically, the bill would require pre-marketing inspections for Class II 510(k) devices, and mandate that all domestic and foreign device facilities be inspected strictly every two years - a change from FDA's de facto risk-based approach to scheduling inspections.

GAO Finds Need For More Inspections

Committee Chairman John Dingell, D-Mich., and Subcommittee Chair Frank Pallone, D-N.J., cited testimony from the Government Accountability Office as support for improving inspections of both domestic and foreign medium-risk device manufacturing plants.

GAO Health Care Director Marcia Crosse reiterated testimony she gave before the subcommittee in January. FDA inspects overseas facilities on average once every six years for high-risk devices and only once every 27 years for medium-risk devices, including some imaging equipment. Crosse said domestic, medium-risk device facilities are inspected once every five years ("¹ Also see "FDA Inspections Of Foreign Device Manufacturers Anemic – GAO Testimony" - Medtech Insight, 4 February, 2008., p. 6).

Crosse also said that, to date, the device industry both here and abroad has not embraced the third-party inspections being pushed by FDA, and has described several disincentives in the program.

Ami Gadhia, policy counsel for the Consumers Union, also favors increased inspections, as well as additional user fees to help pay for them.

Industry Says Inspection Fees Burdensome

Device industry representatives from AdvaMed, the Medical Device Manufacturers Association (MDMA) and the Medical Imaging & Technology Alliance testified against the expanded inspections, pushing for FDA to continue its risk-based inspection approach.

Dynatronics Corp. CEO Kelvyn Cullimore, Jr., who represented MDMA, testified that the pre-marketing inspection requirement for all Class II products would be a "logistical nightmare" and would cause major delays in products getting on the market.

Device industry representatives also opposed the proposed inspection fee as overly burdensome and unfair.

"Inspections are a core function of the FDA, and funding should come from the appropriations process, not industry fees," said Steve Ubl, president of AdvaMed. He added that many of the association's members, particularly small firms, do not have foreign plants, "yet through their fees they would effectively subsidize inspections of foreign companies exporting their products to the U.S."

Ubl and others suggested establishing a new fee targeted only at facilities in countries with less developed regulatory systems, such as China. Ubl says that about 0.01% of medical device implants, instruments and appliances are imported into the U.S. from China, with more than 90% of imports coming from "the highly developed countries of Canada, Australia, the European Union and Japan."

Substitute ISO 13485 Inspections For FDA Audits?

The House panel showed great interest in the possibility of substituting foreign inspections that assess compliance with the international standard ISO 13485 for additional FDA foreign inspections.

ISO 13485 is the international quality system standard for medical device manufacturing, used in Canada and throughout the European Union. Its requirements for device manufacturers are similar but not identical to FDA's Quality System Regulation.

Lillian Gill, senior associate director of CDRH, told the panel that FDA plans to evaluate ISO 13485 inspection reports and figure out "how we can use these, in the future, in lieu of an [FDA] inspection."

Gill added that the agency is currently comparing ISO 13485 and the Quality System Regulation "and preparing to have a public announcement of our adoption of these ISO standards."

Subcommittee ranking member Nathan Deal, R-Ga., asked Gill: "In the event you determine that ISO standards are sufficient to cover FDA responsibility ... would it require that we legislatively build in language that allows you to accept the ISO inspections?"

Gill responded that "if they are harmonized inspections, and we find they are very equivalent to ours, I don't think the legislative changes would be necessary."

Republicans on the panel, including Deal and full committee ranking member Joe Barton, R-Texas, spoke in favor of the industry position.

Barton called the requirement for pre-market inspections of all class II 510(k) devices "overkill and probably not implementable in the real world." He urged the Democratic sponsors to remove the device components of the bill and deal with them separately later.

"If you are going to do a food safety bill, let's do a food safety bill. If we want to do drug safety, let's do a drug safety bill. I think you can combine those, but I do not think medical devices should be part of the bill," Barton said.

In the Senate, Ted Kennedy, D-Mass., is crafting a similar bill. A version circulated earlier this month provides more flexibility for FDA inspection scheduling. Like the House version, it would create a new industry user fee to support inspection activities ("² Also see "Senate Crafts Import Safety Bill, As Device Reps Prep For House Hearing" - Medtech Insight, 12 May, 2008., p. 4).

- Sue Darcey (s.darcey@elsevier.com)

Industry Opposes Idea Of New FDA Inspection Authority, Fee At House Hearing

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