WASHINGTON - A pilot program to shift medical device regulation away from government and onto independent third parties lacks an enforceable time frame to overcome lengthy delays in getting products to market, according to the head of a lobbying association. Jeffrey J. Kimbell, executive director of the Medical Device Manufacturers Association, said the Food and Drug Administra-tion-approved program does not include vital devices such as catheters and shunts.
Some 20 independent organizations, including Underwriters Laboratories Inc., have asked to participate as third-party review groups, said Paul Tilton, spokesman for the FDA Center for Devices & Radiological Health. No drug companies or plastics concerns with interests in medical manufacturing are included in that number, he said.
FDA will accept applications for third-party review status through June 3 and is expected to begin its pilot program a month after that, Kimbell said. FDA accreditation is based on perceived conflict of interest, scientific background and competence of the staff conducting reviews, facilities of the reviewing group and the entity's area of specialization.
Kimbell said MDMA supports stronger third-party review powers as outlined in House legislation. The House bill requires a 90-day response period for the FDA to act on the results of third-party reviewers. Kimbell said, however, that the failure of product liability legislation to receive President Clinton's signature to become law last month ``is a clear indication to us that he will veto third-party review legislation now pending.''