Custom Device Exemption Guidance for Industry and Food and Drug Administration Staff September 2014

GUIDANCE DOCUMENT

• Docket Number: FDA-2013-D-1601
• Issued by: Center for Devices and Radiological Health

The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in Section 520(b) of the Food, Drug and Cosmetic Act (FD&C Act). The guidance provides definitions of terms used in the custom device exemption, explains how FDA interprets the “5 units per year of a particular device type” language contained in section 520(b)(2)(B) of the FD&C Act, describes what information should be submitted in a Custom Device Annual Report (“annual report”), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.

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