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Industry, FDA Start To Settle Into 510(k) Refuse-To-Accept Program

After a rocky start, the rate of 510(k)s being turned away by FDA before full review under the refuse-to-accept program has steadily declined, and industry expects continued improvement.

The proportion of 510(k)s blocked from undergoing a full FDA review upon first submission is declining. This is a good sign for companies who had complained that the agency was going overboard in holding off reviews as part of its nascent 510(k) refuse-to-accept (RTA) program.

FDA turned away almost 60 percent of 510(k) submissions submitted in fiscal year 2013 at least once before initiating a full review under the RTA process. For applications submitted anytime...

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