Medical Device Amendments

[AI summary unavailable — showing source text] Medical Device Amendments - Title I: Classification of Medical Devices - Directs the Secretary of Health, Education, and Welfare, under the Federal Food, Drug, and Cosmetic Act, to appoint and organize separate classification panels of experts to review and classify devices into appropriate categories based on the safety and effectiveness of such devices. Requires such panels to submit recommendations for the classification of devices into one of the three following categories: (1) exempt devices-those devices having a generally accepted medical use which are safe and effective when used according to instructions and warnings and which present a minimum risk; (2) devices subject to standards- those devices for which in order to reduce or eliminate unreasonable risk of illness or injury it is appropriate to establish reasonable standards to assure safety and effectiveness; and (3) devices subject to premarket scientific review-those devices for which inadequate evidence exists to assure safety and effectiveness. Requires the Secretary to publish a report on the device classification scheme in the Federal Register and to allow for comment by interested persons. Title II: Authority to…