Zdrowie i gospodarka · 1.08.1997

Draft Guidance on Medical Device LabelingSuggested Form and Content; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for medical devices entitled ``Medical Device Labeling--Suggested Form and Content.'' The draft guidance is intended to assist the device manufacturers in designing labeling and FDA in evaluating labeling and to promote clarity and uniformity in medical device labeling. The draft guidance identifies a suggested content for device labeling and each element of the suggested labeling is discussed. DATES: Written comments concerning this draft guidance must be received by October 30, 1997. ADDRESSES: Written comments concerning this draft guidance must be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be identified with the docket number found in brackets in the heading of this document. Submit written requests for single copies of ``Medical Device Labeling--Suggested Form and Content'' to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesiv