July 1996 Bulletin

Forum assists FDA on regulatory issues

Provides expertise on device reclassification

The Device Forum, born out of a technology transfer symposium in May 1995, is proving to be a successful cooperative venture between the Food and Drug Administration, Academy, American Orthopaedic Association (AOA), scientists in musculoskeletal care, and the Orthopaedic Surgical Manufacturers Association (OSMA).

The forum has brought together the various parties, as mandated by its mission, "to help realize the public health goal to bring innovative, high quality products to the American public in an expeditious manner."

"This is the first time that all the parties have come together in positive interaction to examine important regulatory issues," said Harlan Amstutz, MD, former president of the American Orthopaedic Association. Dr. Amstutz was chairman of the symposium, "Academic, Industry, and Federal Interactions in Developing and Applying New Technology for Orthopaedics," which recommended the formation of the Device Forum. The AOA, Academy, National Institutes of Health-Musculoskeletal Branch, and the Orthopaedic Research and Education Foundation were co-sponsors of the symposium.

All participate

"The Device Forum allows all the parties to participate in the definition and resolution of regulatory issues that affect all the groups," said Bernard F. Morrey, MD, 1994 Academy president and a member of the steering committee for the 1995 symposium. "The alternative is for the FDA to provide the definition of safety and efficacy in a vacuum. The FDA doesn't have the internal resources to address all these issues; the Device Forum opens up the limited resources of the FDA."

Kimber Richter, MD, director of the FDA's Office of Device Evaluation, views the meetings as "an extremely valuable opportunity to talk about issues with all parties. It gives us perspectives on what issues are important and what would be helpful in the future. It's a unique situation to get so many individuals involved."

Among the issues discussed at the two meetings of the Device Forum has been the reclassification from Class III to Class II of some of the 23 orthopaedic devices which have been exempt from the premarket approval process (PMA). The devices are exempt because they were in use before the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act which gave the FDA expanded responsibility for regulating medical devices. The FDA is planning that by Dec. 31, 1997 the devices either will be reclassified from Class III to Class II or be subject to the PMA process which requires the manufacturers to present evidence, often including extensive clinical data, that there is a reasonable assurance that a device is safe and effective.

The Device Forum has established two work groups to develop information for the reclassification of certain knee and shoulder prostheses. Bernard Stulberg, MD, chairman of the Device Forum, also heads the work group on the knee; Dr. Amstutz heads the work group on the shoulder.

Dr. Morrey will head a work group to develop a reclassification petition for elbow joints. Other reclassification efforts are being initiated. A work group for bone cements also will be formed.

The forum evaluated the initial process by which the guidance document on testing certain implants was reviewed and shared information about how to improve the way in which external input from the scientific orthopaedic community and industry is received.

Discuss guidance

The forum also discussed basic issues related to FDA guidance documents such as the format, scope, and science (clinical relevance), and appropriateness of basic hypotheses.

Forum members representing the scientific orthopaedic community and industry offered their expertise to the FDA in regard to determining and defining scientific validity and encouraging the FDA to interact with other informational resources such as the American Society for Testing and Materials, American Institute of Medical and Biological Engineering, Society of Biomaterials, and Health Industry Manufacturers Association.

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