The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory 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 manufacturers of custom devices is intended to apply only to those who are manufacturing a custom device to fit the needs of a particular patient, so the manufacturer will not be required to file a premarket notification for each particular device,” FDA said.
FDA says the reformed definition of a custom device will ensure clarity and consistency, particularly as some manufacturers might be unaware that certain devices they distribute as custom devices do not meet the statutory definition and are subject to premarket review.
In 2014, FDA issued final guidance on custom device exemptions, explaining the new statutory provisions and defining certain terms used in connection with the custom device exemption and how FDA interprets the devices that may qualify for the exemption.
The guidance also describes in further detail what information should be submitted in an annual report, and provides recommendations on how to submit an annual report for custom devices distributed under the exemption.
The final rule issued Tuesday comes without notice and comment because FDA says it “only corrects the implementing regulation to restate the statute," adding, “[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary.”
A device will qualify as a “custom device,” FDA says, by meeting new statutory requirements, including, among others, that each device:
(1) is created or modified in order to comply with the order of an individual physician or dentist (or other specially qualified person);
(2) necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515 of the FD&C Act;
(3) is not generally available in the US in finished form through labeling or advertising by the manufacturer, importer or distributor for commercial distribution;
(4) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
(5) either (a) is intended to meet the special needs of such physician or dentist in the course of the professional practice of such physician or dentist or (b) is intended for use by an individual patient named in the order of a physician or dentist (or other specially qualified person as designated);
(6) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals, physician or dentist;
(7) may have common, standardized design characteristics, chemical and material compositions and manufacturing processes as commercially distributed devices.
The new provisions for the custom device exemption also include the following limitations: (1) the device is for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;” (2) the production of the device must be “limited to no more than five units per year of a particular device type”; and (3) a manufacturer is required to submit an annual report to FDA on the custom devices it supplied.