On September 24, the Food and Drug Administration (FDA) released a final guidance document clarifying the revised custom device exemption implemented in Section 520(b) of the Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. [1]/ The final guidance provides helpful clarification of various elements of the revised statutory definition of custom devices and associated regulations.

One of the most significant revisions made by FDASIA to the custom device exemption is that it limits distribution to 5 units per year of a specific device type. [2]/ The final guidance clarifies the statute’s ambiguity with respect to what constitutes a unit of a particular device type to count toward the allowed threshold.

In addition, under Section 520(b)(2)(C) of the FDCA, manufacturers must now report to FDA annually on their distribution of custom devices. The report must cover all of the company’s custom devices during the reporting period, even where a transaction – such as a device revision – does not count towards the annual five-unit allotment. All reports will be due in the first quarter of the year, and cover a manufacturer’s activities for the previous calendar year.  Notably, the first custom device report is due by March 31, 2015, and must cover the distribution of all custom devices in the period since FDASIA’s enactment (July 9, 2012).

The guidance specifies FDA’s expectations for these annual reports. Companies should include:

  • An explanation of how the device satisfies each of the elements of the statute and meets the special needs of the patient or physician in the course of professional treatment, such as the following:
    • Why the device necessarily deviates from the premarket requirements such that clinical investigations would be impractical;
    • Whether the device is newly created or modified from an existing legally marketed device to comply with a particular individual physician’s order;
    • Demonstration that the company has made a reasonable, good-faith effort to ascertain that the device is not generally available in the U.S. in finished form through promotion by the manufacturer, importer, or distributor for commercial distribution;
    • A full description of the device;
    • Description of the condition that necessitated use of a custom device and alternative treatments;
    • Assertion that no other device is available in the U.S. to treat the unique pathology or physiological condition, with records to that effect maintained;
    • The unique patient identifier associated with the device, for a patient-centric device;
    • Whether the device is created from components or finished on a case-by-case basis to accommodate unique needs, and a discussion of any similarities to commercially distributed devices.
    • A summary of all custom devices shipped, used, returned, and destroyed, date of manufacture, the product name, brand name, product model number, product catalog number, or other product identifier information, and product code (if applicable). The guidance provides sample tables with the recommended format for providing this information.
    • A signed Truthful and Accurate statement.

FDA intends to request additional information or clarification from product manufacturers where submitted reports do not meet agency expectations, and maintains the authority to take enforcement action or issue Warning Letters for custom device violations.

Custom device reports will require a significant effort to gather and validate the data to be submitted due to the amount of detailed explanation that FDA is requesting.  As described in the guidance, each distribution will require detailed justifications for why the device meets the custom device exemption.  Accordingly, the report will be more involved than simply reporting the numbers of devices distributed by type under the exemption.

Preparation of the first report covering July 9, 2012 to December 31, 2014 may be particularly challenging due to the requirement that companies report on custom device distributions that pre-date the issuance of the final guidance document.  If custom device distributions were not tightly managed after FDASIA was implemented, some of the necessary data may be absent or difficult to access.  Further, upon review of the data, it may be discovered that certain device distributions did not meet all of the criteria for eligibility under the custom device exemption.