July 1997 Bulletin

FDA honors Device Forum, a model of cooperation

The Device Forum is being hailed as a model partnership of government, the orthopaedic scientific community and the orthopaedic device industry.

Honored May 20, 1997 with a special citation from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), the forum is an outgrowth of a 1995 technology transfer symposium. The symposium participants found there was a need for a format to facilitate discussion between various parties involved in the use and development of orthopaedic devices. The mission of the forum is to create an environment of open communication to realize the public health goal of bringing "innovative, high quality products to the American public in an expeditious manner."

The forum brings to the table representatives of the FDA, Academy, American Orthopaedic Association (AOA), Orthopaedic Research Society (ORS), American Society for Testing and Materials (ASTM) and the Orthopaedic Surgical Manufacturers Association (OSMA).

Formed in January 1996, the group's first project was to review FDA guidance documents. The FDA identified the plasma spray (femoral stems) guidance document regarding postmarket testing as the pilot project. The document went through a peer review process to obtain comments from ASTM, ORS, Academic Orthopaedic Society, AOA, OSMA, American Institute of Medical and Biological Engineering and Society of Manufacturing Engineers as well as the Device Forum and the Academy's Committee on Biomedical Engineering.

As a follow-up, the forum developed a more efficient procedure to facilitate the review process. The procedure has worked efficiently for obtaining and compiling comments on reclassification petitions and will be implemented to direct the development of guidance documents.

Rather than developing guidance documents by selecting studies in the literature without understanding what is controversial or that the study represents the bias of an investigator, the FDA now can directly access the expertise of the orthopaedic community, said Bernard N. Stulberg, MD. Dr. Stulberg, chairman of the Device Forum, received the CDRH Director's Special Citation award on behalf of the forum. He also is chairman of the Committee on Biomedical Engineering.

A work group, led by Timothy Wright, PhD, was formed to consider the FDA guidance document on ultra-high molecular weight polyethylene. The work group has rewritten the guidance document and it has been reviewed by industry and the scientific orthopaedic community. The guidance document has been cited by the FDA as an outstanding example of a user-generated document and a model for future guidance documents.

The forum has created work groups to develop reclassification petitions for orthopaedic devices that have been exempt from the premarket approval process (PMA). The devices 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 devices either have to be reclassified from Class III to Class II by the end of 1997 or be subject to the PMA process. The work groups are developing reclassification petitions for:

The forum also is working with Biomet, Inc. to submit a PMA bone cement reclassification petition.

Earlier this year, the Device Forum focused attention on biologics, forming work groups to study safety issues, efficacy issues and animal models.

Jim Dillard, deputy director of the division of general and restorative devices, CDRH, said the value of the forum to the FDA is that "we meet on a regular basis with surgeons, the academic portions of orthopaedic medicine and manufacturers. It has allowed us to move forward and to streamline."

He acknowledged that the FDA, academics and manufacturers had different concerns about issues, but the forum allows the parties to "get together before issues heat up. Not everyone agrees on every issue, but everyone makes an honest attempt to find a solution that is reasonable.

"The public has benefited because we have been able to work through some difficult issues and will allow technologies and devices to reach the public expeditiously."

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