U.S., EU PACT SEEN AS STEP IN LONG PROCESS

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WASHINGTON — Medical device makers may be able to get selected products to market more quickly in the United States and the European Union because of a tentative agreement requiring regulators across the Atlantic to honor some of each other's device-approval procedures. The agreement, which is expected to be ratified by EU member countries, requires the Food and Drug Administration to accept good manufacturing practices inspections carried out in the EU. The deal also requires the FDA to accept third-party inspections of some medical devices in the EU, although the FDA still has final approval.

The agreement is a good first step that sets the stage for further standardization of regulations, although it ``does not get us to one review for both the U.S. and the EU,'' said Matt Gallivan, associate vice president for global strategy and analysis for the Health Industry Manufacturers Association in Washington.

The same company could perform the quality systems inspection in the European Union, for example, but will have to do two inspections, even if they are very similar, he said.

On device inspections, the FDA is expected to begin routinely approving reviews conducted by third parties like EU university laboratories after it gets more confident with European procedures in a few years, he said.

The agreement also calls for accepting about 20 additional devices into the FDA's third-party review, most likely ultrasound, imaging and dental equipment, because those were European priorities, he said. The FDA currently has a small trial project for third-party review domestically.

The agreement also requires the European Union to accept the same type of device and quality reviews done in the United States.

EU countries generally have more-flexible medical device rules, including broader use of third-party, nongovernmental inspectors hired by the companies. But some FDA officials reportedly worried that using EU standards could undercut consumer protection in the United States.

FDA officials could not be reached for comment.

The agreement was reached late last month. It will reduce regulatory costs and speed product development times, and may reduce the ``steady movement'' of U.S. medical device jobs to Europe, HIMA said.

Industry officials interviewed at the Medical Design & Manufacturing East '97 show in New York praised the deal but were unsure about its impact.

``It's a little step toward going toward that bigger step, but whether in a reasonable time frame that little step grows is hard to say,'' said Donald Grabarz, a member-partner in the medical device consulting firm International Regulatory Consultants L.C. The firm has offices in the United States, Switzerland, Belgium, the Netherlands and Germany.

Nancy Hermanson, medical market technical leader for Dow Plastics in Midland, Mich., said: ``It should be a good thing. We'll reserve judgment and see if that's the case.''