Zdrowie i gospodarka · 23.07.1996

Medical Devices; Reporting; Certification and U.S. Designated Agents

The Food and Drug Administration (FDA) is proposing to revise its regulations for medical device manufacturer certification, and to issue conforming certification requirements for distributors. FDA is also announcing its intent to reconsider the requirement for foreign manufacturers to appoint a U.S. designated agent to perform certain duties under the adverse event reporting final rule that was published in the Federal Register of December 11, 1995. FDA is taking this action in response to comments from industry raising concerns that have not been addressed previously. Elsewhere in this issue of the Federal Register, FDA is announcing a stay of the effective date of the manufacturer certification and U.S. designated agent provisions and the revocation of the May 28, 1992, distributor certification provisions. This proposed rule will assist FDA in protecting the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended uses while reducing the regulatory burden on reporting entities.