The FDA has exempted more than 70 Class I devices from pre-market notification requirements—seven of which are subject to some limitations.
The list of exempt devices includes a range of instruments, from clinical chemistry and clinical toxicology devices to some neurological and radiological devices.
Exemptions from premarket notification requirements are, in some cases, limited to specific devices within a listed device type. For example, FDA lists the “exemption of the ataxiagraph device as 510(k) exempt, but limits the exemption to such devices that do not provide an interpretation or a clinical implication of the measurement.
Under the 21st Century Cures Act, the FDA was required to publish the determination within 120 days of the date of enactment of the law, and at least once every 5 years thereafter, as the agency deems appropriate.