FDA

The U.S. Food and Drug Administration (FDA) published a final rule Tuesday that amends its regulations on the definition of a custom device to include new legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exempt from 510(k) and premarket approval (PMA) submissions.

“The final rule explained that the exemption for custom device manufacturers is intended to apply only to those who manufacture a device that is customized to meet the needs of a particular patient, such that the manufacturer will not be required to file a premarket notification for each individual device,” the FDA said.

According to the FDA, the reformed definition of a custom device will provide clarity and consistency, especially since some manufacturers may not be aware that some devices they distribute as custom devices do not meet the statutory definition and are subject to premarket review.

In 2014, the FDA issued final guidance on the custom device exemption, explaining the new statutory provisions and defining certain terms used in connection with the custom device exemption and how the FDA interprets which devices qualify for the exemption.

The guidance also describes in more detail the information that must be submitted in an annual report and provides recommendations on how to submit an annual report for personalized devices distributed under the exemption.

The final rule published Tuesday is without notice or comment, as the FDA states that it “corrects only the implementing regulations to restate the law,” adding: “[W]hen regulations merely restate the law they implement, notice and comment procedures are not required.”

Details

A device will be considered a “custom device,” according to the FDA, by meeting the new statutory requirements, including, among other things, that each device:

(1) is created or modified to comply with the order of a physician or dentist (or other specially qualified person);

(2) necessarily deviates from an otherwise applicable performance standard under section 514 or a requirement under section 515 of the FD&C Act;

(3) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor; distributor for commercial distribution;

(4) is designed to treat a unique pathology or physiological condition that no other device is available nationally to treat;

(5) either (a) is intended to meet the particular needs of that physician or dentist in the course of that physician's or dentist's professional practice or (b) is intended for use by an individual patient named in a prescription from a physician or dentist (or other specially qualified person designated);

(6) is assembled from components or manufactured and finished on a case-by-case basis to meet the unique needs of individuals, physicians or dentists;

(7) may have common and standardized design features, chemical and material compositions, and manufacturing processes as devices distributed in commerce.

The new provisions for the custom device exemption also include the following limitations: (1) the device is intended to treat a "condition that is sufficiently rare that it is impractical to conduct clinical investigations on the device"; (2) production of the device must be “limited to no more than five units per year of a particular type of device”; and (3) a manufacturer is required to submit an annual report to the FDA on the custom devices it has supplied.