FDA Custom Device Exemption Still Won't See Much Use

Law360, New York (March 4, 2014, 5:19 PM EST) -- On Jan. 14, 2014, the U.S. Food and Drug Administration announced the availability of a draft guidance, “Custom Device Exemption.” The FDA requests that parties submit comments within 60 days of publication by March 17, 2014.


Custom devices are medical devices designed to treat a unique pathology or physiological condition that no other device is domestically available to treat, or intended to meet the practitioner’s special needs in the course of professional practice.

Under Section 520(b) of the Federal Food, Drug, and Cosmetic Act ("FDCA"),...
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