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Compliance In Focus
Posted by Brandy Chittester on Wed, Dec 5, 2012

Improvements in Device Review- Are Things Finally Turning Around?

For quite some time we’ve watched the blame for slow review times pass between industry andImprovements in Device Review FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry? According to a new report on FDA’s website, the plan implemented in January 2011 aimed to modernize and improve the premarket review of medical devices is working. This development seems promising as the speed and predictability of medical device review has improved for the first time in almost a decade- according to FDA’s report.

Listed below are some benchmark improvements concerning the 510(k) program, which gives a look into the benefits industry is already realizing as the result of the plan. Improvements include:

  • The average time it takes to clear a 510(k) began declining in 2011, for the first time since 2005;
  • The backlog of 510(k)s pending for more than 90 FDA-days, which increased steadily since 2005, dropped by almost two-thirds, from its high in 2010;
  • The average time it takes to reach a decision on a PMA has been reduced by about one-third since 2010; and
  • Without lowering the bar for clearance or approval, the percentage of submitted 510(k)s that are cleared and PMAs that are approved has increased since 2010, indicating improvements in the quality of applications and the consistency of review standards.

 The obvious benefit of these improvements rests first and foremost with the patients. FDA notes, “The turnaround in the length of premarket reviews and decrease in backlogs will produce important benefits for patients and the medical device industry.” In fact, this Plan of Action is the response of CDRH’s discovery that the biggest obstacle in the premarket review process was unpredictability.

In addition to the Plan of Action implemented in January 2011, FDA has also instituted several programs to create a supportive environment for medical device innovation in the US. The report specifically mentions:

  • The Innovation Pathway is designed to bring safe and effective breakthrough devices to market more quickly and at lower cost, in part through intense early collaboration between the FDA and device innovators
  • The FDA is creating incentives for device developers to conduct their clinical studies first in the U.S.

Will these actions by FDA allow the US to maintain its stand as a leader in the medical device segment? These improvements seem to benefit all parties, what do you think? Check out the full report and share your thoughts below.

Photo Credit: dmelchordiaz

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Topics: Device Review, FDA, CDRH, 510(k)


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