Not all class I or II medical devices are required to undergo a premarket notification process with the FDA. Additionally, certain preamendment unclassified devices are considered to be sufficiently well understood that they, too, do not require premarket notification. Under the 21st Century Cures Act, FDA was given the authority to exempt class II and class I reserved medical devices from premarket notification requirements on a periodic basis. This guidance (an update to earlier guidance from AUG2015) contains that list of exempt devices. The list includes several product codes; for example, code EWD for an inserted hearing protector, or LRL for hemorrhoid cushions. Exemption from premarket notification does not include exemption from the general controls requirements in the law (such as labeling). 

This issuance is a good reminder that the agency frequently revises its regulatory approach to different devices, meaning sponsors should consult the medical devices website for updated information before and during development and submission of new or improved devices.

Text Copyright © 2019 Katrina Rogers