FDA Announces Certain Class II Devices Exempt from Premarket Notification Requirements

Today’s Federal Register announces the FDA’s exemption of a list of certain class II devices from premarket notification [510(k)] requirements. This finalizes the proposed list of devices the FDA published in the Federal Register for public comment in November 2017. The exemption of these class II devices will decrease regulatory burdens on the medical devices industry and reduce costs required to comply with federal regulations while allowing patients continued access to safe and effective devices.

The 21st Century Cures Act, signed into law on December 13, 2016, updated the process for FDA’s ability to exempt from 510(k) requirements class II devices that the FDA believes are sufficiently well understood and do not present risks that require 510(k) review to provide reasonable assurance of safety and effectiveness.

Medical device types that are exempt from 510(k) are not exempt from other FDA regulatory controls, unless such exemption is explicitly provided by order or regulation.  For example,  generally, 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 current establishment registration and device listing with the FDA.

Additional Information for Sponsors of 510(k)s for Device Types that are Now Exempt or Exempt with Limitations:

• Sponsors with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to certain limitations, should contact the 510(k) lead reviewer to discuss if their device falls within the general limitations of exemption per 21 CFR 862.9 to 892.9 (i.e., the device is exempt and the sponsor may choose to withdraw their submission or receive a “device is exempt” decision letter) or exceeds the limitations (i.e., review of the 510(k) should continue).
• Sponsors with cleared 510(k)s for device types that are now considered exempt are not required to take any action at this time.
• Sponsors with cleared 510(k)s for device types that are partially exempt from 510(k) must make a determination whether their specific devices are exempt or non-exempt. Partial exemption limitations can be found in table 1 of the Federal Register Notice.  Manufacturers should follow existing regulations and guidance regarding when a 510(k) is required to be submitted if a device is determined to be non-exempt.
• Device labelers that have submitted device identifiers records to the Global Unique Device Identification Database (GUDID) for devices types that are now exempt or partially exempt from 510(k) requirements should be aware that changes may need to be made to these record(s) in the future. 
• The FDA is working on updates to the GUDID to make it easier to make changes to device identifier records.  We will notify affected labelers when the database updates have been completed and provide further information and instructions.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 ordice@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health