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April 24, 2007

FDA proposals for update to Medical Device User Fee and Modernization Act (MDUFMA II)

The FDA is soliciting public comments on its proposals to Congress for MDUFMA II. These proposals are meant to ensure prompt approval of medical devices that have shown efficacy and safety. Public comment will be accepted until the middle of May, with a public meeting to be held on April 30.

This fee program has industry cover the costs of the FDA's pre-market review program.

Main proposal points:

Performance goals - "FDA would reach a decision on 50 percent of expedited pre-market approval (PMA) applications and expedited supplement applications within 180 days; 90 percent within 280 days. In addition, FDA would reach a decision on 90 percent of 510(k) applications within 90 days; 98 percent within 150 days." The FDA will report its performance record on a quarterly basis.

Help for small business -

  •   no fees for first-time PMA submissions to small businesses with $30 million or less in annual sales or receipts;
  • further reductions in full fees for 510(k) application submissions (from 80 percent to 50 percent) and for PMA submissions and related supplements (from 38 percent to 25 percent) for small businesses with $100 million or less in annual sales or receipts; and
  • a provision for foreign business entities to qualify as small businesses.

Predictable fees - "Manufacturers would continue to pay fees when they submit applications for some types of medical devices, but at a lower and more stable rate than under the current program. The proposal would add several additional fees, which would generate about 50 percent of the total fee revenue and be more stable than application fees."

Fact Sheet: FDA Legislative Package for Next Medical Device User Fee Program (April 16, 2007)

For more information, visit www.fda.gov/cdrh/mdufma/.

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