Medical Panel Sets Out Recommendation Guidelines

The Oregon Medical Advisory Committee (MAC) announced the guidelines it will use in making recommendations to the administrator of the Workers' Compensation Division and the director of the Department of Consumer and Business Services. The MAC reported that U.S. Food and Drug Administration approval is "necessary but not determinative." "For a new device, '501(k) approval' is not sufficient." The MAC reported that when the Medical Device Amendment to the Federal Food, Drug and Cosmetics Act passed in 1976, Section 510(k) helped the FDA handle the increase in requests for approval. "By subm...