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Compliance In Focus
Posted by John Lehmann on Mon, Feb 6, 2012

Do The FDA & Medical Device Industry Finally Agree?

The tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act (MDUFMA) is long awaited good news! IMARC covered the story of how the FDA missed the MDUFMA proposed deadline, January 15th, in a previous blog. But, luckily it looks like the medical device industry and the FDA were able to find common ground.

As reported by The Advanced Medical Technology Association (AdvaMed), the device industry lobby and trade group, the goals agreed to by the FDA and industry include:

  • Achieve reductions in total review times, measuring from the time of submission to the time FDA makes a decision on a premarket application (PMA) or a 510(k) submission. The total time is the most meaningful measure of the approval process;
  • Achieves significant performance improvements for premarket approval (PMA) and 510(k) applications relative to current performance;
  • Leave "no submission behind" by requiring FDA to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing work on the submission;
  • Provide a substantive interaction with applicants halfway through the targeted time for completion of review, thus ensuring that a company can have time to properly respond to appropriate questions; and
  • Implement an analysis of FDA’s management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.

MassDevice also covered this story. They draw attention to medical device manufacturers agreeing to double user fees. In fact, that article states, "Medical device manufacturers agreed to re-authorize the FDA's user fee program and double the payments industry will pay to $595 million over the next 5 years." MedCity News also covered the piece; check out the article which asks the question- "Is the FDA asking too much?"

In short, what does all this really mean? AdvaMed's president & CEO, Stephen J. Ubl, summarized the agreement best. He states, "The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics. The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process."

Isn't that the common ground for all? Benefiting patients with a safe, effective framework that allows bench-side to bed-side innovations?

What do you think of the proposed agreement?

Topics: AdvaMed, FDA


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