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Compliance In Focus
Posted by John Lehmann on Wed, Mar 21, 2012

Moving Forward: The Medical Device User Fee Act

Medical Device CRORecently MassDevice covered the announcement that the proposed recommendations for the Medical Device User Fee Act (MDUFA) were cleared by the House Subcommittee.

For background, MDUFA has three particularly significant provisions for the FDA:

• User Fees for Premarket Reviews
• Establishment of Third-Party Inspections
• New Regulatory Requirements for Certain Devices

The most talked about provision, of course, entails the new fees which will double the fees that the industry currently pays to the FDA- from $287 million to $ 595 million over the next five years. As a result of the increase costs, the industry hopes the FDA will improve the regulatory pathway making it more speedy, predictable, and reliable.

This latest approval comes as progress to the tentative agreement between the FDA and Medical Device Industry, which IMARC covered in a blog last month. The next steps for MDUFA include:

• 30 days for the public to comment on the act
• FDA will revise the draft recommendations as necessary
• The act will proceed to Congress for final approval

Already the industry has embraced this step as a promising step forward. In fact, The Advanced Medical Technology Association (AdvaMed) released a statement that “the agreement will require consistent and efficient administration by FDA leadership, as well as appropriate congressional oversight.” AdvaMed also notes that “it is in the interests of patients and the American economy that this agreement functions well, and we will work with FDA to help make that happen.”

Check out the article in MassDevice, and AdvaMed’s press-release. How do you feel about the progress of MDUFA? Do you have any comments on the act? Share them with us!

Topics: MDUFA, FDA


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