The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002. MDUFMA has three particularly significant provisions: - User fees for premarket reviews. Premarket applications (PMAs), product development protocols (PDPs), biologic license applications (BLAs), certain supplements, and 510(k)s are now subject to fees. The revenues from these fees, and from additional appropriations for infrastructure, will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry. A small business (sales and receipts of $30 million or less) may pay a reduced fee. The payment of a premarket review fee is not related in any way to FDA’s final decision on a submission.
- Establishment inspections may be conducted by accredited persons (third-parties), under carefully prescribed conditions.
- New regulatory requirements for reprocessed single-use devices, including provisions requiring the submission of additional data on devices now being reprocessed, and a new category of premarket submission, the premarket report.
MDUFMA makes several other significant changes that are less complex or have a narrower scope than the major changes discussed above. FDA will provide additional information on these provisions in the near future: - Additional appropriations for postmarket surveillance are authorized. The Act authorizes significant additional appropriations to strengthen FDA’s postmarket surveillance of medical devices marketed in the United States. For FDA to actually receive these resources, Congress must pass appropriations acts authorizing these additional funds to FDA.
- The existing third-party 510(k) review program is continued through FY 2006.
- The review of combination products (products that combine elements of devices, drugs, or biologics) will be coordinated by a new office in the Office of the Commissioner.
- Electronic labeling is authorized for prescription devices intended to be used in health-care facilities.
- FDA may require electronic registration of device establishments, when feasible.
- The sunset provision applicable to section 513(i)(1)(E) (intended use based upon labeling) is revoked.
- The law now explicitly provides for modular review of PMAs.
- New provisions are added concerning devices intended for pediatric use.
- GAO and NIH are directed to prepare reports concerning breast implants.
- The manufacturer of a device must be identified on the device itself, with certain exceptions.
| 
