Life Sciences

MDUFMA II calls for new fee structure, additional small business relief

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 23, 2007

The FDA last week proposed reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II). Here's a run-down of some key aspects of the proposal.

  • Fee structure: The proposal calls on manufacturers to continue to pay fees when they submit certain applications, but at a lower rate than the current program. Fees would be assessed on facilities that register with the FDA as a manufacturer, and annual report filing fees would be collected for pre-market approvals.

  • Performance goals: The FDA has set performance goals for itself and would report quarterly on how it is meeting those goals. For example, the FDA aims to reach decisions about 50% of expedited pre-market applications and expedited supplement applications that go before an FDA advisory committee within 180 days, and 90% within 280 days.

  • Small business relief: Payments from businesses with $100 million or less in annual sales or receipts would be reduced from 80% of the full fee to 50% for 510(k) applications and to 25% from 38% for pre-market approvals and related supplement fees. Foreign businesses may also qualify for small businesses.

    The MDUFMA II proposal also calls for greater FDA transparency, a streamlined third-party inspection program, and new guidance for in vitro diagnostic devices. Go to the FDA Web site to read more.

    • Most Popular

    Related Articles