Agency changes include medical device review - Inside FDA

FDA Consumer, Nov, 1996 by Dixie Farley

Private organizations may be allowed to participate in evaluating medical devices under a pilot program that began Aug. 1.

The program is one of several FDA initiatives in what Vice President Al Gore termed "a common sense approach" to streamlining, simplifying and reducing the regulatory costs of the medical device industry while maintaining public health and consumer safety. "The result is safe, new medical devices that will be available to the American people in record time," Gore said when FDA announced the initiatives in April.

Other initiatives change the way FDA inspects certain device firms and reduce the number of environmental assessments that industries, mainly the food and drug industries, have to prepare for FDA's review.

Third-Party Review

This initiative tests whether third-party review of medical devices will reduce review times and whether strong conflict-of-interest rules can be maintained in such a process.

The program applies only to low- and moderate-risk devices for which FDA does not require clinical data on safety and effectiveness - products such as electronic thermometers and surgical gloves. A manufacturer must show in a premarket notification application that such a product's safety and effectiveness are comparable to a device already legally marketed. Each year, FDA receives about 1,500 applications for low- and moderate-risk devices that would qualify for third-party review.

Participation in the pilot program is voluntary. Firms may choose to have most of the review by a third party, or leave the entire procedure up to FDA.

If a firm does choose third-party review, this is how the program works: * The firm selects an organization FDA has recognized for participation in the program. * The firm submits its application to the organization. * When the review is complete, the organization submits the application, the review results, and a recommendation to an FDA supervisor for final assessment. This bypasses the first phase of the agency's routine review process. * Within 30 days, FDA makes its decision.

"The test for any reform is whether it protects the public health," said FDA Commissioner David A. Kessler, M.D. "Our proposal will test whether this speeds up the process and if the integrity of the review can be maintained."

FDA will closely monitor the pilot program, which will run for two years, and make any necessary changes to protect the public health. The agency announced the program in the April 3, 1996, Federal Register.

New Inspection Procedures

Another initiative, also a pilot program, changes the way FDA inspects firms with a good history of compliance with agency requirements. The changes were jointly developed by FDA and a task force of industry officials following "grassroots" meetings FDA held with device manufacturers last year. If successful, it will be expanded to manufacturers of other products regulated by FDA.

Among other changes, FDA will: * Notify firms of inspection in advance, instead of inspecting unannounced, as previously done. Advance notice would enable the firm to prepare for the visit and be better ready to answer questions. * Give firms opportunity to note on the official inspection record violative findings that were corrected immediately. In the past, FDA records listed only the findings, without noting immediate corrections. * Give firms found in compliance a letter informing them they successfully passed the inspection. In the past, FDA has not given such recognition.

Fewer Environmental Assessments

Although the third initiative affects mainly the food and drug industries, it also applies to the medical device industry and other FDA-regulated areas. The proposal would streamline and simplify FDA's procedures for complying with the National Environmental Policy Act. The proposal greatly reduces the number of environmental assessments the industries have to prepare for FDA's review.

FDA found that many actions for which it presently requires such assessments have no significant effect on the environment. By eliminating them, the agency can focus greater resources on areas that present real potential for environmental impact. The proposed reforms would add no environmental risks, FDA believes. They would save the industries as much as $15 million and the agency as much as $1 million each year. Some firms are already beginning to submit abbreviated assessments under informal guidance by FDA.

The initiatives are among more than 40 reforms identified by FDA and the Vice President's National Performance Review program to make the U.S. government work better and cost less.