CDRH Industry: Class II Devices Exempt from Premarket Notification: Request for Comments

Today’s Federal Register announces a list of 1,003 class II devices that the FDA is proposing to exempt or partially exempt from the premarket notification [510(k)] requirements.  The FDA believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. The Agency periodically exempts from premarket notification review such medical devices when appropriate, the last time being in 2015.  The FDA is publishing this notice and requesting public comment in accordance with streamlined procedures established by the 21st Century Cures Act.

Medical devices that are exempt from 510(k) are not exempt from other regulatory controls. All medical devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.

Please submit comments on the proposed list no later than May 15, 2017.  Instructions for submitting comments can be found in the Federal Register Notice.

The FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health