Superseding an initial guidance issued in August 2015, the FDA has released an updated guidance on the exemption of certain medical devices from 510(k) requirements entitled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.”
This exemption aims to achieve two goals: decrease regulatory burdens on the medical devices industry and reduce costs required to comply with federal regulations, while allowing patients continued access to medical devices.
Additionally, 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 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, according to the FDA.
“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,” the agency said in a prepared statement.
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 until the publication of a final rule exempting these devices from 510(k).
See the entire updated guidance here.