FOOD AND DRUG ADMINISTRATION ISSUES PROPOSED RULE: MEDICAL DEVICES; CLASSIFICATION OF ACCESSORIES DISTINCT FROM OTHER DEVICES; PROPOSED LIST OF ACCESSORIES SUITABLE FOR CLASS I; REQUEST FOR COMMENTS

WASHINGTON, Aug. 17 -- Food and Drug Administration has issued a proposed rule called: Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.

The proposed rule was published in the Federal Register on Aug. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA is publishing...