Zdrowie i gospodarka · 18.07.1997

Medical Device Reporting, Guidance Document for Manufacturers; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Medical Device Reporting (MDR) for Manufacturers.'' The guidance describes the new medical device reporting requirements for manufacturers, and it is intended for both domestic and foreign medical device manufacturers. The MDR regulations provide a mechanism for FDA to identify and monitor significant adverse events involving medical devices so that problems may be detected and corrected in a timely manner. ADDRESSES: Submit written requests for single copies of the ``Medical Device Reporting (MDR) for Manufacturers'' guidance document to the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Requestors will be sent a floppy diskette with a Microsoft Word document file containing the guidance document. See the Supplementary Information section for electronic access to the draft guidance.