The Food and Drug Administration (FDA) has issued a Draft Guidance clarifying the parameters of the custom device exemption contained in section 520(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and new reporting requirements for customs devices mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA). The Draft Guidance explains FDA’s interpretation of the statutory exemption as modified by FDASIA and describes a significantly detailed and comprehensive annual report to be submitted by manufacturers of custom devices each year under the new law.

Custom devices are devices created to meet the medical needs of either a specific patient or to meet the sufficiently unique special needs of the individual doctor or dentist’s practice.  A single custom device cannot be both a patient specific device and a device intended to satisfy the unique doctor or dentist’s practice needs. Custom devices are exempt from premarket approval (PMA)

or performance standards under premarket notification (510(k)) clearances, however, they remain subject to medical device Quality System Regulation, including design controls, medical device reporting, corrections and removals, and registration and listing.

Making Multiple Units of a Custom Device

FDASIA introduced the potential to make and distribute multiple units (up to five units per year) of a device type under the custom device exemption.  In the Draft Guidance, FDA interprets “five units” as meaning five new patients for the patient-created custom device or five new doctors/dentists

for the practitioner-created custom device. This number includes all the custom devices ordered by and remaining with the patient or practitioner. Thus, if a manufacturer provides extra custom units in, for example, different sizes, for a unique case and only one satisfies proper sizing needs, the devices not used will not count against the manufacturer’s yearly limit if the unused devices are returned to the manufacturer, not used for a subsequent valid custom device case, and not redistributed without a valid marketing authorization.  FDA will also count bilateral custom devices (e.g., for bilateral joint replacement) as one unit, so long as the replacement procedures occur during the same reporting year.

What is a Custom Device? Investigational, Compassionate Use, Pediatric and Patient-Matched Devices

Since a custom device is intended to treat rare patient conditions or rare physician needs when a suitable device is not available in the U.S., a device that can be studied under an IDE would not meet the custom criteria. The patient population for a true custom device would be too small to support a clinical study. Thus, a device being tested with or without an IDE and that is the only option for a patient is not a custom device. Nevertheless, the device could be available to a patient if the study sponsor seeks compassionate use approval from FDA before the device is employed. The sponsor would submit an IDE supplement with the request for the protocol deviation to treat the patient, but the device approved for compassionate use would not be a custom device. Likewise, pediatric devices are not automatically custom devices as they too can be studied. However, a pediatric device could qualify as a custom device if it otherwise meets the regulatory criteria.

FDA further explains that a 510(k)-cleared device that is modified but which maintains the original

intended use and could be clinically studied would not be considered appropriate as a custom device. However, if an existing 510(k)-cleared device is modified to treat a unique pathology or physiological condition, to the extent that it cannot be the subject of a clinical study, it may qualify as a custom device.

FDA also notes that devices that are approved or cleared to meet a range of specifications supported by data in the submission are likewise not custom devices. The devices, known as “patient-matched” devices, may be manufactured when ordered by a physician or dentist, but they are not custom devices because both the device and the patient population can be identified and studied.  Further, in these instances, FDA has cleared or approved the wide range of specifications in the marketing application for the device and so the specific size or other patient-matched characteristic of the device is available commercially in the U.S.

Annual Reporting Requirements

FDASIA added a new reporting requirement for custom devices. The custom device manufacturer must report annually to FDA certain information about the custom devices it manufactured and distributed in the United States during the prior calendar year.  The first report must include retrospective information on custom devices provided by the manufacturer beginning with the date of FDASIA’s enactment (July 9, 2012) to the date of the first report, due by March 31 of the following calendar year.

Importantly, FDA states in the Draft Guidance that it does not intend to enforce the reporting requirements until one year after the date of the final Guidance.  However, FDA encourages manufacturers to report information required by the statute before the Final Guidance Document issues and in the Draft Guidance has laid out a format and procedure for submitting that information in hard and electronic copies. The FDA is encouraging annual reporting on a voluntary basis before the final Guidance is available. The Annual Report should include among other items:

  • A cover letter identifying the manufacturer, the custom devices and the signature of the responsible company official
  • A signed Custom Device Annual Report Truthful and Accurate Certification Statement
  • Information to support the custom device classification
  • A summary of custom devices shipped, used, and returned
  • Details of the custom device use, including patient information, physician/dentist information, and custom device or custom device component information.
  • Appendixes to the Draft Guidance include a:
    • Format for Summary Data Tables,
    • Custom Device Annual Report Truthful and Accurate Statement, and a
    • Customs Device Decision Tree designed to help manufacturers determine whether the devices will meet

the requirements of a custom device classification.

Comments on the Draft Guidance should be submitted within 60 days after its announcement in the Federal Register on January 14, 2014.

A copy of the Draft Guidance is available here.