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Start Over Subjects United States ✖Remove constraint Subjects: United States Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

4561. Feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 6, 2022
Subject(s):
Clinical Studies as Topic
Diabetes Mellitus, Type 2 -- drug therapy
Glycemic Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4564. E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):
Adverse Drug Reaction Reporting Systems
Drug and Narcotic Control
Electronic Mail
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4565. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 16, 2022
Subject(s):
Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4566. Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 6, 2022
Subject(s):
Electromagnetic Fields
Equipment Design -- standards
Equipment Safety -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4569. Recommendations to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2022
Subject(s):
Blood Component Transfusion -- legislation & jurisprudence
Creutzfeldt-Jakob Syndrome -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration