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Start Over Subjects Government Regulation ✖Remove constraint Subjects: Government Regulation

164. Unique device identification: Policy regarding compliance dates for class I and unclassified devices, direct marking, and Global Unique Device Identification Database requirements for certain devices : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 25, 2022
Subject(s):
Databases as Topic
Equipment and Supplies
Government Regulation
Product Labeling
United States
United States. Food and Drug Administration

167. Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):
Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

169. Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):
Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
United States. Food and Drug Administration