Custom Device Exemption Draft Guidance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On January 14, 2014, FDA issued the draft guidance “Custom Device Exemption.”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 concepts and procedures for custom devices, such as:”

  • devices created or modified in order to comply with the order of an individual physician
  • multiple units of a device type (no more than 5 units/year) qualifying for the custom device exemption
  • annual reporting requirements by the manufacturer to FDA about custom devices

The Custom Device Exemption Draft Guidance discusses:

  • The term “five units of custom devices per year”
    • The FDA “interprets the five units in terms of five new custom device cases per year (i.e., five new patients for the patient-focused custom device or five new physicians for the physician-focused custom device, assuming all other required elements for the custom device exemption are satisfied). The five unit limitation includes all devices provided by a manufacturer to, and remaining in the possession of, the ordering physician and/or the patient” (FDA)
    • Questions, answers, and examples of custom devices:
      • Custom devices are exempt from PMA requirements, but not “exempt from any other requirements, including… Quality System Regulation, Medical Device Reporting, Corrections and Removals, and Registration and Listing.” (FDA)
      • Devices that do not qualify for a custom device may still qualify for compassionate use.
      • Current 510(k) devices may be considered custom if the device is altered to treat a unique condition.
  • Annual reports must be given to the FDA regarding custom devices.
    • “The manufacturer of the custom device must report to FDA annually, as required by section 520(b)(2)(C) of the FD&C Act, on the custom devices it supplied. The annual report should include the number of patients who received a new device or revisions of a previous custom device.” (FDA)


FDA requests that comments on the draft guidance be submitted by March 17, 2014.

Read the full draft guidance here.