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Long-Awaited Guidance Clarifies Custom Device Requirements

Posted 13 January 2014 | By Alexander Gaffney, RAC

US medical device regulators have released a draft guidance detailing how sponsors and manufacturers of so-called "custom" medical devices can comply with US Food and Drug Administration (FDA) regulations.


Custom medical devices can be thought of as being similar to products made by pharmaceutical compounders: They are similar to already-approved devices, but are custom-made to the specifications of a single patient based on their prescribed needs as determined by a healthcare professional.

Like compounded products, custom devices are mostly exempt from regulation, and are not required to seek premarket approval or clearance. However, they are required to meet standards for good manufacturing practices (GMPs) under FDA's quality system regulation (QSR, 21 CFR 820).

The devices are defined per 21 CFR 812.3(b) as devices not being generally available, not available in finished form, deviated for the needs of a specific patient, not advertised for commercial distribution and intended for a specific patient.

But as with pharmaceutical compounding, the line between a product that requires approval and one allowed to bypass regulatory approval is not always clear. In April 2009, for example, FDA won a case before the US Court of Appeals for the Eleventh Circuit against manufacturer Endotec, which the court found was manufacturing devices and marketing them as "custom" when they were actually subject to FDA regulation. Though FDA won the case, The Gray Sheet reported that left unanswered by the courts was an important question: What line separates a custom device from a commercial one?

The issue was controversial-and important-enough to warrant inclusion in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, Section 617 of which clarified the definition of "Custom Devices" and called upon FDA to issue final guidance to clarify requirements by August 2014.

Since then, FDA has listed the guidance as among its most important, but a planned August 2013 release date for the guidance came and went.

Custom Device Exemption

But after a long wait, FDA has now finally released the text of its draft guidance for industry: Custom Device Exemption.

In it, FDA focuses on some of the more difficult and controversial provisions of the custom device regulation that have long troubled manufacturers.

For example, Section 520(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act)-the section of the law that governs custom devices-maintains that manufacturers can make no more than five units per year of a particular device type. Otherwise, the law, modified by FDASIA, states they must seek premarket approval.

FDA said that this "five units" clause will be measured in individual cases, such as five new patients or five new physicians. "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 added. Extra units manufactured to accommodate potential sizing concerns will not count toward the total so long as the extras do not enter commercial distribution and are destroyed, FDA continued.

Questions and Answers

The remainder of the guidance focuses on two aspects: Assorted questions and answers, and the annual reporting requirements for manufacturers of custom devices.

Some notable answers from the guidance:

  • With the exception of GMPs, premarket requirements to not apply to custom devices.
  • A device subject to an IDE cannot be a custom device.
  • A custom device cannot be intended to meet the specific needs of both a physician's practice and a patient's unique physiological/pathology needs.
  • Devices that do not meet the custom device exemption requirements may still qualify for compassionate use under an investigational device exemption (IDE).
  • Modifications to an existing 510(k)-cleared device would not be considered appropriate for a device seeking a custom device exemption, but it can be if it is intended to treat a unique pathology or physiological condition under narrow circumstances.
  • Servicing a device does not count against the five-unit yearly limit, provided that certain limitations are met (e.g. servicing is done to meet the needs of the patient).
  • Pediatric devices are not automatically custom devices.
  • Custom devices should meet all labeling requirements under 21 CFR 801.1, as well as contain a statement that the device is intended for a custom population.
  • Custom devices may not be marketed to the general public.

The guidance also explains the requirements associated with submitting an annual report, which should include the number of patients who received a new device or a revised version of an existing device, the number of devices manufactured and distributed, and other relevant information.

Comments are due by 14 March 2014.

Custom Device Exemption Guidance

Federal Register

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