- Manufacturer Requirements
- Requirements for User Facilities
- Other Provisions
On July 31, 1996, the new medical device reporting (MDR) regulations for medical device manufacturers and user facilities became effectiveat least for the most part. The long-awaited regulations, which were published in the Federal Register on December 11, 1995, implement adverse event reporting provisions of the Safe Medical Devices Act of 1990 (SMDA) and amend existing reporting requirements for manufacturers as required by the Medical Device Amendments of 1992.1 FDA's distributor reporting regulations are unaffected by the new regulations.2
FDA first promulgated regulations to require manufacturers and importers of medical devices to report certain adverse events to the agency in September 1984.3 In doing so, FDA was acting pursuant to section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device Amendments of 1976, which authorized FDA to issue regulations requiring manufacturers, importers, and distributors of medical devices intended for human use to establish and maintain records, make reports, and provide information to FDA as may reasonably be necessary to ensure that devices are not adulterated or misbranded and are otherwise safe and effective for human use.4
Congress amended section 519 with passage of SMDA to: (1) require certain medical facilitiescalled "device user facilities"to report certain adverse device events to device manufacturers and/or FDA, and to submit semiannual reports to FDA summarizing MDR reports for the previous six months; (2) require FDA to issue regulations to implement the statutory provision for distributor adverse event reporting; and (3) require manufacturers and distributors to certify to FDA the number of MDR reports submitted in a year, or to certify that no such reports were submitted for the year.5
Section 519 was amended again by Congress under the Medical Device Amendments of 1992, this time to provide a single reporting standard for reports of injuries to FDA made by manufacturers, importers, device user facilities, and distributors, and to provide a single definition for the types of injuries that these entities must report.6 The 1992 amendments also authorized the agency to issue regulations requiring user facilities, manufacturers, importers, and distributors to report significant adverse device experiences that do not fall within the definitions of reportable deaths, serious injuries, or malfunctions, but that FDA determines are necessary to be reported.7
The statutory provision requiring user facility reporting became effective 12 months after the date of the enactment of SMDA, on November 28, 1991. Two days before the effective date, FDA published a tentative final rule to implement SMDA's new statutory provisions for adverse device event reporting for distributors and device user facilities.8 While the distributor reporting regulations in the tentative final rule became final by operation of law on May 28, 1992, FDA did not finalize any regulations to implement the statutorily mandated user facility reporting requirements until the new MDR regulations were published in December 1995.
Edward M. Basile is a partner and Elizabeth A. Schmidtlein is an associate specializing in FDA law in the Washington, DC, office of King & Spalding. The authors acknowledge the assistance of their colleagues Dvorah Richman and Holly Dolbey.