Zdrowie i gospodarka · 31/05/1996

Medical Devices; Medical Device User Facility and Distributor Reporting; Guidance Documents; Availability

The Food and Drug Administration (FDA) is announcing the availability of three guidance documents entitled ``Medical Device Reporting: An Overview,'' ``Medical Device Reporting for User Facilities,'' and ``Medical Device Reporting for Distributors.'' These guidance documents provide information to help facilitate compliance with the agency's Medical Device Reporting (MDR) requirements. The agency is also announcing the availability of the following final MDR reporting forms: FDA Form 3419, Semiannual User Facility Report; FDA Form 3417, Baseline Report; and FDA Form 3381, Annual Certification. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of, and requesting comments on, a draft guidance document focusing on reporting by manufacturers.