Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration

The Food and Drug Administration (FDA) is issuing regulations requiring medical device user facilities and manufacturers to report adverse events, related to medical devices, under a uniform reporting system. This regulation is mandated by the Safe Medical Devices Act of 1990 (SMDA) and prescribes the conditions under which reports must be submitted, the content and timing of the requisite reports, and how FDA will utilize the information in carrying out its public health protection responsibilities. This rule is intended to augment the agency's postmarket surveillance activities and public health protection responsibilities relating to medical devices. In the future, FDA will propose to revoke the distributor adverse event reporting regulations that went into effect on May 28, 1992, by operation of law and replace them with provisions based on notice and comment. FDA will also propose to fully implement its authority under the Medical Device Amendments of 1992 (the 1992 amendments).