Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; Stay of Effective Date; Revocation of Final Rule

In response to numerous requests for the Food and Drug Administration (FDA) to consider further comments concerning medical device reporting (MDR) certification and U.S. designated agent requirements, FDA is staying the effective date of these two specific provisions of the adverse event reporting final rule that was published in the Federal Register of December 11, 1995. Specifically, these provisions relate to manufacturer certification and U.S. designated agent requirements. In addition, for consistency purposes, FDA is revoking the distributor reporting certification requirement that went into effect on May 28, 1992.