The FDA is exempting 120 medical device classes from premarket notification and review requirements, RAPS reports. This should lessen the cost for device development – and make them easier to market.
Currently, the FDA regulates three categories of medical devices: Class I, which are low-risk devices that are exempt from premarket notification; Class II, which are moderate-risk and require a 510(k); and Class III, which require a PMA.
The new guidance is meant to exempt certain unclassified, Class I and Class II devices from premarket notification requirements. As RAPS writes, such exemptions can save medical device companies a lot of cash:
Having a device regulated as a lower-risk product is advantageous for companies, as it allows them to avoid costly user fees, lengthy regulatory review times and many of the costs associated with developing a product.
For example, consider the cost to submit a Class III device using a PMA in 2015: $250,895. In comparison, a Class I device exempt from submitting a 510(k) would cost the company nothing to submit. Another benefit: A Class I device requires no fee to market each year, whereas a Class III device must pay $8,781 to FDA each year to remain on the market.
Even a 510(k) is somewhat expensive–$5,018 per application, though most of its true costs come from obtaining the data necessary to show its equivalence to existing devices or adherence to established standards.
The sorts of devices that are being exempted from premarket notification include a number of surgical lights, hearing aids and baths. Click here for a complete list of the 120 exempted devices.
Photo: Big Stock Photos
