Arundhati Parmar of highlights the ongoing struggle for medical device companies to earn approval from the FDA in a timely manner. In 2012, a guidance document stated that FDA would notify a company within fifteen days of submission on whether or not their 510(k) will be accepted for further review. However, 58% of these submissions through September 2013 received Refuse to Accept (RTA) response letters. Jorge Ochoa, Principal Engineer in Biomedical Engineering at Exponent, an engineering and scientific consulting firm comments, “Industry pushed for faster responses from the FDA, and now industry has basically one shot to get it right before the clock gets reset.” In addition, Ochoa stated, “With an unlimited amount of RTA cycles, theoretically you can continuously file amended RTAs, which is the dangerous part of the regulatory process.”

Ochoa and several of his colleagues also noted that many companies receive RTA letters as a result of minor specificities. One example provided by Carrie Kuehn of Exponent, was that the company’s submission had two pages numbered 17.

It is important for staff to be knowledgeable on the demands of the RTA checklist, as well as understand the bigger risks leading to RTAs within the device description and substantial equivalence sections in the 510(k) document. To read the full article, click here. To view the FDA guidance entitled “Refuse to Accept Policy for 510(k)s,” click here.

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