Nearly 60% of Firms with 510(k) Submissions Got FDA's Refuse-to-Accept Letters in 2013

Posted in Regulatory and Compliance by Arundhati Parmar on May 13, 2014

That rate is troubling, said industry experts at the 10x Medical Devices Conference in Minneapolis. 

Medical device companies have long complained that FDA takes too long to approve devices.

In late 2012, as part of an agreement with industry ratified by Congress, the agency updated a previous guidance document that essentially says that a company will hear from FDA in 15 days whether a 510(k) submission is going to be accepted for more detailed review.

Known as the Refuse-to-Accept policy, 2013 was the first year in which 510(k) submissions had to clear that hurdle before obtaining a substantive review under the new guidelines. As of September, FDA received 2965 510(k)s and refused to accept 1715. A refusal rate of 58% through September 2013 is troubling, said industry experts at the 10x Medical Devices Conference in Minneapolis Tuesday, scheduled to close Wednesday.

Getting a refuse-to-accept letter basically means that schedules of new product development is affected. 

Industry pushed for faster responses from FDA, and now industry has basically one shot to get it right before the clock gets reset, explained Jorge Ochoa, principal engineer, biomedical engineering at consulting firm Exponent, a speaker at the conference. 

The RTA process is not interactive and there are unlimited number of RTA cycles, which Ochoa described as the really dangerous part of the regulatory process because in theory you can continue to file amended RTAs ad nauseam.

In 2013, Ochoa and his colleague at Exponent heard several anecdotes related to why so many companies got Refuse to Accept letters. Here are three examples from their presentation:

  • Failure to state whether a condom was patient contacting
  • Failure to indicate whether a vinyl glove contained software or met the electrical safety requirements
  • Typos, misprints and duplicate pages

In fact Ochoa's colleague Carrie Kuehn noted that one story she heard of why a company received the letter was because it had two pages numbered 17 in its submission.

The RTA checklist is very detailed and the agency is not really asking for safety and efficacy information, said Robert Packard, a regulatory and quality assurance expert with Medical Device Academy and another panelist.

"They are asking you to dot your i's and cross your t's and to do it 10 times and then it will be almost good enough for them to reject," Packard said tongue in cheek.

Ochoa said that it's important to understand that the biggest risks likely to lead FDA to send a RTA are in the device description and the substantial equivalence portions of the document. He also advised that the entire organization and not simply regulatory folks should be trained on interacting with the FDA and the demands of the RTA checklist.

Learn more about FDA communication strategies at the MD&M East Conference & Exposition, June 9-12 in New York City

In conclusion, Kuehn, senior managing scientist at Exponent, noted that things may get better this year in terms of the percentage of companies that receive the RTA.

However, "RTA is not going anywhere," she cautioned. "The link between substantive review and administrative review (which is what the initial review should be) has been blurred. 


-- By Arundhati Parmar, Senior Editor, MD+DI


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