FDA Guidance on Exemptions

FDA Guidance on Exemptions for Custom Devices

In FDA, Regulatory by Valynda Machen

On September 24, FDA issued the final document on Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff. This guidance is meant to clarify the language in section 520(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), describe what information should be included in a Custom Device Annual Report, and how the annual report should be submitted.

The Custom Device Exemption is a provision in section 520(b) of the FD&C Act that allows device manufacturers to distribute devices without a premarket approval (PMA), as long as the device meets the following requirements:

  • It is created or modified to comply with the order of an individual physician or dentist
  • It is not generally available in the US
  • It is designed to treat a unique condition that no other device is available to treat
  • It is intended to meet the special needs of the physician or dentist in the course of his or her practice or is intended for use by an individual patient named in the order
  • It is assembled or manufactured and finished on a case-by-case basis to meet the needs of the order
  • It is intended to treat a sufficiently rare condition, such that conducting clinical investigations would be impractical
  • Its production will be limited to no more than 5 units per year of a particular device type
  • The manufacturer must report to FDA annually on any custom devices it has provided

The new guidance clarifies the limitation of “no more than 5 units per year” to mean 5 new custom device cases (5 new patients or 5 new physicians) per year. This would not include extra units produced because of size concerns as long as those extra devices are not used and would not apply in a situation where a patient would need multiple devices of the same type (such as bilateral implants) so long as the devices are ordered together.

The guidance goes on to discuss the Custom Device Annual Report required by section 520(b)(2)(C) of the FD&C Act, including what information should be included and how best to submit the report to allow for faster FDA review.

Manufacturers who provide custom devices to patients and physicians in need should be familiar with this guidance document. Regulatory experts at NAMSA can help ensure the appropriate measures are taken by:

  • Providing regulatory expertise and advice
  • Preparing the Custom Device Annual Report
  • Managing communication with FDA

Next Step

  • Subscribe to our blog to stay informed on industry news and insights,
  • Contact Valynda Machen for more information about this topic, and
  • Visit our Regulatory Consulting page to learn more about NAMSA’s regulatory services.


US Food and Drug Administration. Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff. September 24, 2014.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM415799.pdf.


Valynda Machen (CQA, RAC-US) has over 20 years of medical device experience in the areas of In Vitro Diagnostic (IVD) manufacturing, new product development, quality assurance and regulatory affairs. She holds a B.S. in Bacteriology from Iowa State University and obtained certifications in quality auditing and regulatory affairs. Valynda is currently a Senior Medical Research Manager for NAMSA.