Medical Device User Fee and Modernization Act (MDUFMA) of 2002

The MDUFMA was enacted largely to improve the efficiency and predictability of the medical device review process. Among other provisions, MDUFMA authorizes the FDA to impose user fees for premarket reviews of certain medical device applications. In exchange, the FDA is expected to meet certain performance goals designed to expedite and improve medical device reviews. The user fees, paid by medical device makers seeking premarket approval, will help advance the device approval process, reduce time to market, and allow consumers earlier access to new treatments and technologies. Furthermore, the FDA has broadened its review process by allowing manufacturers to utilize third parties to conduct their FDA-required inspections. The MDUFMA has four particularly significant features:

• User fees for premarket reviews of Premarket Applications, Product Develop­ment Protocols, Premarket Reports (a new category of premarket application for reprocessed single-use devices), Biologics License Applications, certain supplements, and 510(k)s.

• Performance goals for many types of premarket reviews. These goals become more demanding over time, and include FDA decision goals and cycle goals (cycle goals refer to FDA actions prior to the sponsor’s final action 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 a new category of premarket submission, the premarket report.

In an effort to reduce the burden on small businesses, the FDA provides a reduced rate for firms that meet the definition of a small business under FDAAA.12 The definition of a small business has not changed since 2006, that is, $100 million or less in gross sales and receipts of all affiliates, partners, and parent firms. Small firms with gross sales of $30 million or less would be eligible to have the fee on their first PMA waived. New for FY08, there is a mecha­nism for firms based outside the United States to qualify for a small business fee reduction.

Fees for Premarket Notification [510(k)s] and Premarket Application