Historical
ADA TR 1081-2015
FDA’s Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
Once it was recognized that this rule was going to take effect, practitioners needed to have an understanding of this rule and what it will entail as it is required to go into practice, from a clinician side. The manufacture chain and responsibilities have been clearly identified by the FDA, but the clinical use has not; and thus that was determined to be the main focus of this paper. This paper covers the UDI Rule (78 FR 58786) and device marking regulations in 21 CFR 801.45. It does not cover the regulations for medical device tracking found in 21 CFR 821. There is no tracking requirement within the UDI rule.
CONTENT PROVIDER
American Dental Association [ada]
American Dental Association [ada]