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Compliance In Focus
Posted by John Lehmann on Fri, Jul 7, 2017

FDA User Fee Financial Impact

I ran across an article in a recent edition of Medtech Insight that focused on the 10 key details from US FDA agreements that will impact medical device and diagnostics companies. The article indicates that the US FDA user-fee reauthorization legislation is proceeding through Congress, most recently with a May 11 markup in the Senate Health, Education, Labor and Pensions Committee. Lawmakers would like to see a bill passed in July.

The core details of the user-fee reauthorization agreements will have a signification impact on FDA User Fee Financial Impact-2.jpgcompanies’ day-to-day regulatory operations in the fiscal 2018-2022 period. The article summed up the financial impact as follows:

  • The 510(k) submission fee will increase 2% to 3.4% of the base PMA fee rate, but small businesses will only have to pay one-quarter of the standard 510(k) fee, rather than the 50% rated in MDUFA III.
  • The new de novo classification fee will be set at 30% of the PMA rate.
  • The base user-fee rates will be adjusted for inflation, and can also conceivably be increased to meet revenue targets if submissions/registrations are below projections.
  • User-fee rates cannot be reduced as a result of prior-year over-collections

Many device industry group hope that Scott Gottlieb, the new FDA Commissioner who was sworn in on May 11th advocates that Congress move for quick passage of the user-fee reauthorization and FDA reform legislation.

Please share your thoughts on the pending user-fee reauthorization legislation.

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Topics: Congress, FDA, user-fee reauthorization

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