The U.S. Food and Drug Administration (FDA) has issued a Final Order that exempts certain Class II medical devices from the agency’s premarket notification (510(k)) requirements.
Published in the U.S. Federal Register, the Order lists five different types of Class II medical devices that will no longer require premarket notification. The device types include certain mass spectrometry test systems, genetic health risk assessment systems, as well as other purpose-specific devices.
The FDA says that devices exempted under the Final Order: 1) do not have a significant history of false or misleading claims or risks associated with their use; 2) have well established characteristics regarding their safe and effective performance; 3) when modified, changes that could affect safety and effectiveness will be readily detectible or will not materially increase risk; and 4) future changes are unlikely to affect the device’s classification.
The FDA’s Order regarding Class II medical device exemptions came into effect on June 5th. The FDA encourages applicants with pending 510(k) submissions for devices which may now be exempt from premarket notification requirements to contact the agency to determine if their device falls within the limitations of the exemption specifications.
The FDA notes that an exemption from 510(k) requirements does not exempt either the device or the device manufacturer from other applicable requirements, such as good manufacturing practice requirements or packaging and labeling requirements.