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Date: Wednesday, April 3, 1996
FOR IMMEDIATE RELEASE
Contact: Food and Drug Administration, Sharon Snider (301) 443-3285

FDA ANNOUNCES REFORMS OF MEDICAL DEVICE PROCEDURES

The Food and Drug Administration today announced initiatives that will streamline, simplify, and reduce the regulatory costs of the medical device industry while maintaining important public health and consumer safety protection.

"Under the leadership of President Clinton, the FDA is adopting a common sense approach to regulating the medical device industry," said Vice President Gore, whose National Performance Review program includes regulatory reform as part of the effort to make the federal government work better and cost less. "The FDA is eliminating unnecessary and burdensome regulations while still maintaining critical public health protection. The result is safe, new medical devices that will be available to the American people in record time."

One initiative, will test whether allowing private organizations to participate in evaluating medical devices will reduce review times and whether strong conflict-of-interest rules can be maintained in such a process.

"This pilot program is another example of FDA's innovative regulatory strategy for the 21st Century," said HHS Secretary Donna E. Shalala. "It explores how the agency can best review relatively low-hazard products while enabling the agency to target its resources where the risks are high."

"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."

The pilot third party review program will only apply 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. Manufacturers are required to show in premarket notification (510k) applications that products in this category are comparable in safety and effectiveness to a device already legally marketed. FDA receives about 1,500 applications of this type a year.

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

If an outside review is chosen, the manufacturer selects an FDA-recognized third party and submits to it the marketing application. The organization reviews the product and submits the application, the results of its review, and its recommendation to an FDA supervisor for a final assessment, thereby bypassing the first phase of FDA's routine review process. An agency decision will be made within 30 days.

FDA will closely monitor the pilot program and make any necessary changes to protect the public health. The program is expected to begin in mid-summer and run for two years. In the near future, FDA will announce the date of an information meeting for prospective third party reviewers to clarify the criteria for their eligibility for participation in the program.

FDA's second initiative is the result of a series of "grassroots" meetings with medical device manufacturers conducted last year by the agency as part of the National Performance Review. The nationwide exchanges, which were focused on FDA's inspections for compliance with federal standards, resulted in an initiative jointly developed by FDA and a task force of industry officials. The proposed changes of FDA inspection procedures will apply to firms with a good history of past compliance with FDA requirements.

These changes include:

advance notification of inspection instead of the routinely conducted unannounced inspections. The prior announcement will enable the firm to prepare for the inspector's visit and be better ready to answer questions;
an opportunity for firms to note on the official inspection record violative findings that had been immediately corrected. In the past, FDA records listed only the findings, regardless whether or not they had been corrected immediately; and
a letter from FDA informing firms found in compliance that they had successfully passed the inspection, a recognition that was not accorded in the past.

The program will begin immediately as a pilot project. If successful, it will be expanded to other manufacturers of FDA-regulated products.

The third initiative affecting mainly the food and drug industries, but also applicable to the medical device industry, is a proposal that would streamline and simplify FDA's procedures for complying with the requirements of the National Environmental Policy Act. The proposal, which the agency will soon publish, covers all FDA-regulated product areas and greatly reduces the number of environmental assessments the industries have to prepare for FDA's review.

The agency has found that many of the actions for which it presently requires environmental assessments have no significant effect on the environment, and their elimination will enable FDA to focus greater resources on those areas that present real potential for environmental impact. The agency believes that these reforms will result in no additional risks to the environment, while saving the industry annually as much as an estimated $15 million, and the agency as much as $1 million.

The announced initiatives are part of a series of over 40 individual reforms that have been identified by the FDA and the National Performance Review. The two medical device programs will begin immediately. The proposed elimination of most environmental assessments will be submitted to public comment, with final regulations expected later this year. Meanwhile, some manufacturers are already beginning to submit abbreviated assessments under informal guidance issued by FDA.