Updated Regulations on Custom Devices
On October 12, 2016, FDA issued a final rule on custom devices designed to implement provisions of the Food, Drug, & Cosmetic Act, FD&CA.
The rule makes the following changes:
§807.85 Exemption from premarket notification
- A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.
- A custom device means a device within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.
FD&CA §520(b) [21 USC 360j: General provisions respecting control of devices intended for human use] has the following general provisions.
A custom device:
- is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);
- in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title;
- is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;
- is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or
(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);
- is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and
- may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.
There are also limitations:
- such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;
- production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and
- the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.
On September 24, 2014, FDA-CDRH issued the guidance document Custom Device Exemption.