FDA Issues Draft Guidance on Custom Devices

Exemption for Custom Devices Remains Narrow -

On January 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Custom Device Exemption. The draft guidance describes how the Agency interprets the custom device provision in section 520(b) of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360j(b), as modified in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA). Specifically, the draft guidance explains how FDA will apply the statutory criteria for a custom device, including the “five [custom] units per year of a particular device type” requirement and describes the information that FDA expects manufacturers’ required annual reports to contain, if the Agency finalizes the draft guidance. The draft guidance suggests that FDA will continue to narrowly construe the custom device exemption and that the Agency expects manufacturers to carefully consider whether a device type meets the criteria and document such determinations. Comments on the draft guidance must be submitted by March 17, 2014, and should reference docket number FDA-2013-D-1601.

Custom Device Exemption and Definitions -

FDASIA revised the FDCA’s custom device exemption that allows manufacturers to provide custom devices without obtaining premarket approval or clearance. Section 505(b)(1) of the FDCA defines a custom device as a device that...