On January 13, 2014, the U.S. Food and Drug Administration (FDA) released a draft non-binding guidance document titled “Custom Device Exemption.” The draft guidance aims to clarify the implementation of changes to the custom device exemption in the Food and Drug Cosmetic Act (FD&C Act). Companies that manufacture custom devices, or plan to in the future, should consult this guidance document.

The custom device exemption allows certain custom devices, for patients or physicians, to forgo FDA premarket approval requirements under the FD&C Act § 514-15. In 2012, provisions of the exemption were changed by the Food and Drug Administration Safety and Innovation Act (FDASIA). Two changes to the exemption are discussed in detail in the guidance: 1) FDASIA’s requirement that custom devices are limited to no more than five units of a particular device per year, and 2) the requirement that manufacturers must now submit an annual report for devices distributed under the exemptions.

Annual Five Unit Limit Per Device

The FDASIA states that devices that qualify for the exemption are “limited to no more than five units per year of a particular device type.” The guidance clarifies this requirement to mean a device is limited to five new “cases” per year. This means a device may be manufactured to meet the special needs of up to five new patients or physicians. If a device is revised for an existing patient, it will not count toward the limit if the revision is required to meet the special needs of the patient. Devices that are distributed by the manufacturer and remain in the possession of the patient or physician count toward the limit. FDA does not count extra devices that are produced for sizing concerns, as long as the non-fitting devices are returned to the manufacturer. Patients that require multiple devices to treat separate anatomical locations, such as a double knee procedure, will only count as a single device toward the limit, but the procedures requiring the multiple devices must occur in the same reporting year.

Annual Reporting Requirement

The changes to the custom device exemption create a new annual reporting requirement. The FDA guidance document outlines what manufacturers should include in an annual report and it is to be submitted.

The guidance states that the annual report should generally include the number of patients or physicians who received a new custom device, how many devices were distributed, and how many were returned. The annual report should include devices that were distributed to revise an existing device (not a new device), but those devices will not be counted toward the annual limit. An annual report should cover a calendar year, and the first report should include information regarding all devices distributed since the enactment of FDASIA on July 9, 2012.

When submitted, a report should include: a cover letter; certification statement; an explanation of how each device satisfies Section 520(b) of the FD&C Act; a summary of custom devices shipped, used, and returned; and information on each patient or physician and their accompanying device. Once again, these are non-binding recommendations by the FDA, but the guidance provides the FDA’s interpretation of how a device manufacturer should fulfill the requirements of the exemption most efficiently.

Comments and suggestions should be submitted by March 17, 2014. Electronic comments can be submittedhere. The full text of the draft guidance can be found here.