FDA Finalizes List of Class II Devices for 510(k) Exemption

July 20, 2017By Rachael E. Hunt

On July 11, 2017, in the Federal Register, FDA published the finalized list of Class II devices that are now exempt from the 510(k) requirements. This list is identical in substance to the proposed list published on March 14, 2017 (see our prior post here). The only change noted is that FDA grouped those products that contain a limitation on the exemption, and those that do not. Companies with products in the former category are well advised to carefully read the limitations that apply to their product to make sure that they do not fall within a limitation. If they do, a premarket notification will be required. The limitations vary, including, for example, a partial limitation for enzyme immunoassays for amphetamine. For those immunoassays, the exemption applies only where the test system is intended for employment or insurance testing. The same test system used for other purposes, for example Federal drug testing programs, would not be subject to the exemption.

Notably, all products are subject to the .9 limitations, which require a manufacturer to obtain 510(k) clearance for an exempt device type, if either: (i) the device is intended for a use different from the intended use of a legally marketed device in that generic type of device; (ii) the device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; or (iii) if it falls within an enumerated list of IVDs, such as those used in the screening or diagnosis of familial or acquired genetic disorders.

Lastly, FDA notes in the Federal Register that companies with pending 510(k) submissions for devices now exempt from premarket notification, when taking into consideration any applicable limitations on those exemptions, should withdraw their submissions.

*Rachel Hunt not admitted in the District of Columbia.

Categories: Medical Devices