FDA Guidance on Exemption of Certain Medical Devices from 510(k) Requirements

FDA Guidance on Exemption of Certain Medical Devices from 510(k) Requirements

Today the U.S. Food and Drug Administration (FDA) issued guidance, “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.”

This exemption of certain unclassified medical devices from 510(k) requirements 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.

This guidance was previously issued on August 14, 2015, formerly entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.” This guidance is revised to exclude product codes that are already exempt through actions associated with the 21st Century Cures Act. Unclassified, Class II, and Class I reserved devices that are not listed in this guidance or included in other exemption notices or otherwise exempt from 510(k) requirements by regulation, still require a 510(k) submission.

In a commitment letter drafted as part of the reauthorization process for the Medical Device User Fee Amendments of 2012, the FDA committed to identifying low-risk medical devices to exempt from 510(k) requirements. In addition, the 21st Century Cures Act, signed into law on December 13, 2016, granted the FDA authority to exempt from 510(k) requirements Class II and Class I reserved devices the agency believes are sufficiently well understood and no longer warrant 510(k) review prior to allowing the manufacturer to market the device.

Medical devices that are exempt from 510(k) are not exempt from other statutory and regulatory requirements, including but not limited to registration and listing, labeling, good manufacturing practice requirements and Medical Device Reporting requirements.

Until the publication of a final rule exempting these devices from 510(k), the FDA does not intend to enforce compliance with 510(k) requirements for these devices and does not expect manufacturers to submit 510(k)s for these devices.

Questions?

If you have 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.