Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. (Read more about class I, II, III medical devices and bringing your medtech products to market here).
Medical device De Novo classification
According to the FDA website, its De Novo process provides a way for medtech companies to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the medtech device’s intended use, but for which there is no legally marketed predicate device. Standard 510(k) medical devices have a predicate.
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Submissions vs volume of submissions approved are below, followed by novel medtech device approval by sub-sector.
De Novo 510(k) submission volume
De Novo 510(k) approval volume
For the above, blue shading represents volume YTD, gray shading denotes pro-rated full year volume as of November 21, 2019.
SEE ALSO
Understanding FDA cleared vs FDA approved devices and equipment
Equipment manufacturer new product development (NPD) plan
A report by investment bank Wells Fargo on FDA trends reveals the number of novel device submissions has declined recently (for reasons that currently unclear to the bank) and, the FDA has increased its post-market surveillance of medtech devices.
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