Custom Device Exemption Draft Guidance

OMEDtechNews & Events

On January 14, 2014, FDA issued the draft guidance “Custom Device Exemption.”  This document provides clarification about the custom device exemption from the Food and Drug Administration Safety and Innovation Act (FDASIA) and applies clarification to the custom device exemption contained in section 520(b) of the FD&C Act. “The new provision amended an existing custom device exemption and introduced new … Read More