FDA Final Order Exempts Certain Class I and II Medical Devices from 510(k) Premarket Review

On December 30, 2019, the Food and Drug Administration issued a final order that exempts certain class I and class II medical devices from 510(k) premarket review, subject to certain limitations. FDA’s action should decrease the regulatory burden on the medical device industry and eliminate private costs and expenditures associated with complying with certain federal regulations.

The FDA order includes a wide range of devices, such as a breath-alcohol test system, a glucose test system, a preformed plastic denture tooth, and certain neurological and radiology products. The final order contains the complete listing of final determinations.  FDA must publish its determination regarding exemption status for certain class I and class II medical devices at least once every 5 years, as it considers appropriate.

Background

FDA published the final list of exempt devices according to procedures established by the 21st Century Cures Act. The Cures Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require FDA to identify through publication in the Federal Register:

• any type of class I device that it determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness; or
• any type of class II device (with at least a 60-day comment period) that it determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness.

Once FDA publishes a final list of devices in the Federal Register, the agency will no longer require a 510(k) for that type of device and the classification regulation for the device will be considered amended to incorporate the exemption.

In the April 13, 2017 Federal Register, FDA issued a notice of final determination to exempt a list of class I devices, subject to certain limitations. In the March 14, 2017 Federal Register, FDA issued a notice proposing to exempt a list of class II devices, subject to certain limitations. After the 60-day comment period, FDA issued a notice of final determination in the Federal Register of July 11, 2017 to exempt the class II devices provided in the proposed list. The final order from December 2019 amends the codified language for each listed classification regulation to reflect FDA’s final determination for the class I and class II exemptions.

Exemption Criteria

A class I device is exempt from the 510(k) requirements unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury.

For a class II device, FDA considers a number of factors to determine whether a class II device qualifies for exemption from the 510(k) requirements.  FDA discussed those factors in the January 21, 1998, Federal Register notice and subsequently in the guidance issued on February 19, 1998, “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff.” Some of these factors include:

• the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device, g., device design or materials; and
• the characteristics of the device that are necessary for its safe and effective performance are well established.

FDA also partially limited some exemptions from premarket notification requirements to specific devices within the listed device type. If a partial exemption limitation exists, FDA has determined that a 510(k) for these devices is required.

AGG Observations

• These exemptions signify FDA’s efforts to reduce regulatory burden while continuing to ensure the safety of marketed medical devices.
• An exemption from the 510(k) requirement does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation.
  • Medical device companies with exempt devices must continue to comply with existing regulatory requirements, g., applicable current good manufacturing practice requirements, establishment registration, and product listing.

For questions, please contact Alan Minsk.