On October 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) held a webinar for industry to explain the guidance document, Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff (“Custom Device Exemption Guidance”), that issued on September 24, 2014. During the webinar, FDA discussed the new guidance and answered questions from stakeholders. Slides from the webinar, as well as a complete recording of the webinar, are available on FDA’s website.

The webinar and the Custom Device Exemption Guidance describe FDA’s thinking associated with implementation of section 520(b) of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 360j(b), as modified by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). Specifically, the guidance and webinar provide FDA’s interpretation of the statutory criteria for exemption of custom devices from premarket review requirements, focusing in particular on how the Agency construes the annual limit of five custom devices per device type for each manufacturer and the information that must be included in an annual report to be submitted to FDA. The final guidance contains some key differences from the draft guidance, including clarification of the term “product type” as it relates to the five device cap. Although the guidance, as finalized, contains some added flexibility, the custom device exemption remains a narrow exemption to standard premarket approval or clearance requirements. Comments on the guidance may be submitted at any time and should reference docket number FDA-2013-D-1601.