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ADA Technical Report No. 1081 FDA's Unique Device Identification Program for Dental Devices-DOWNLOAD - ADA1081-2015
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(DOWNLOADABLE PRODUCT) This paper covers the UDI Rule (78 FR 68786) 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.