FDA is proposing to tighten up exemptions for custom devices under 21 CFR 812.520(b). According to the FDA Law Blog:
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.
The current definition of a custom device is much broader:
(b) Custom device means a device that:
(1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
FDA is accepting public input on the appropriate use of custom devices through January 18, 2013.