FDA Publishes a New List of Class II 510(K) Exempted Devices
On July 11, 2017, the US Food and Drug Administration (FDA) has finalized the list of 1,003 types of class II 510(K) exempted medical devices. According to the agency these devices do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. The complete list of exempted medical devices can be found at https://federalregister.gov/d/2017-14453.
However, FDA clearly stated that the exempted devices are not exempt from other regulatory controls, unless such exemption is explicitly provided by order or regulation. As all 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 FDA.
Implications for medical device manufacturers, importers, labelers and distributors
- Device Manufacturers with existing 510(k) registrations do not have to take any immediate actions.
- Device Manufacturer or 510(k) applicants with pending 510(k) registrations should get in touch with their lead FDA reviewers to determine whether their devices fall under the new exemption rules.
- Device Manufacturers, importers and distributors should review their registration information to see whether they should continue using their existing product codes that require 510(k) premarket notification, or if their devices qualify for new product codes and exemption from 510(k) requirements.
- Device labelers whose devices are exempt may need to amend their Unique Device Identification (UDI) data in the Global Unique Device Identification Database (GUDID).
Global Regulatory Partners will continue monitoring these developments and will keep updating readers if the FDA publishes additional information that may affect medical device 510(k) registrants.[/vc_column_text][/vc_column][/vc_row]