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Medical Devices / Regulatory Affairs

FDA Posts Evaluation Summaries for More Than 100 De Novo Devices

April 28, 2017
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FDA has posted evaluation summaries for more than 100 medical devices classified as de novo with low to moderate risk.

The list includes summaries for such devices as a noninvasive nerve stimulator, an esophageal cooling system, a hearing aid and a strep throat assay.

There are two options for de novo classification for novel devices of low to moderate risk.

Option 1: Any person who receives a not substantially equivalent (NSE) determination in response to a 510(k) submission may, may submit a de novo request within 30 days for the FDA to make a risk-based evaluation for classification of the device into Class I or II. Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.

The agency says the de novo summaries can also serve as a resource for the types of information device manufacturers may wish to use as a predicate for future 510(k) submissions.

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