The U.S. Food and Drug Administration has issued draft guidance regarding the implementation of the custom device exception in the Food, Drug and Cosmetic Act.
The guidance offers definitions, information on what should be submitted in a Custom Device Annual Report and other recommendations on submitting the annual report.
The FDA is accepting comments on the draft guidance for the next 60 days.
To view the draft guidance in full, please click here.
More Articles on the FDA:
FDA Approves First Gel Sealant for Leaking Cornea After Cataract Surgery
FDA Recalls Covidien's Puritan Bennett 840 Ventilator
FDA, Google X Researchers Meet, Spur Rumors of New Device