FDA Exempts Some Class II Devices From Premarket Notification

As part of its efforts to reduce regulatory burdens on devicemakers and to implement provisions of the 21st Century Cures Act, the FDA issued a final rule exempting certain Class II devices from 510(k) premarket notification requirements, effective June 5.

Under the 2016 legislation, the FDA may exempt a Class II device from submitting a 510(k) if there is “reasonable assurance” of the safety and effectiveness of the device.

The FDA issued guidance in November 2017 listing the following factors that it would consider to exempt a Class II device from a 510(k) requirement:

• The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device;
• Characteristics of the device necessary for its safe and effective performance are well established;
• Changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and
• Any changes to the device would not be likely to result in a change in the device’s classification.

Even when exempting devices the FDA may also decide that the devices would be subject to certain limitations. Devicemakers with pending 510(k) submissions for devices that are now exempt from 510(k), subject to the limitations, should withdraw their submissions, the agency said.

The agency received one comment on the guidance that objected to the exemption for genetic health risk assessment system devices, arguing the proposed one-time FDA review would not provide sufficient oversight to ensure the analytical and clinical validity of the tests, and consumers could be misled about the accuracy of the tests.

Read the final rule here: www.fdanews.com/06-06-18-ClassIIRule.pdf.