Section 520(b) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") exempts “custom devices” from the performance standards or premarket approval ("PMA") requirements of sections 514 or 515 if certain criteria are met. The Food and Drug Administration Safety and Innovation Act ("FDASIA"), signed into law in July 2012 (see here), amended section 520(b). Though Congress may have been trying to make it easier for a manufacturer to qualify for the custom device exemption, the FDASIA amendment appears to have enumerated additional requirements, making it more difficult to meet the exemption.
As amended, section 520(b) will exempt devices from the requirements of section 514 or 515 if the device:
- Is “created or modified in order to comply with the order of an individual physician or dentist” or other specified healthcare practitioner;
- Must deviate from a requirement of section 514 or 515 in order to comply with the order of the practitioner;
- “[I]s not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”;
- “[I]s designed to treat a unique pathology or physiological condition that no other device is domestically available to treat”;
- Is intended to meet the special needs of a practitioner “in the course of the professional practice” of the practitioner or is “intended for use by an individual patient named in such order” of the practitioner;
- Is made on a case-by-case basis “to accommodate the unique needs of individuals” described above.
Additionally, to qualify as a custom device, the device must be “for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical,” production of the device must be limited to no more than five per year of a particular device type, and the manufacturer of the custom device must notify FDA annually about the production of such devices.
Earlier this week, FDA issued a notice stating that the Agency is now seeking “information on and examples of appropriate uses of the custom device exemption.” 77 Fed. Reg. 69,488, 69,488 (Nov. 19, 2012). In particular, FDA is seeking information related to instances where the manufacturers or healthcare practitioners have used, would like to have used, or plan to use, the exemption; product areas other than orthopedic and dental devices in which the exemption may be useful; and how often custom devices are ordered to due a unique need of the practitioner (as opposed to the patient).
Historically, FDA has taken a very restrictive view of custom devices. The amended criteria required will result in fewer devices qualifying for the custom device exemption. Hopefully the comments will provide FDA with a better understanding of the types of patients, practitioners, and circumstances that would result in appropriate use of the exemption.