FDA Posts Evaluation Summaries for More Than 100 De Novo Devices
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.