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4444. Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency (revised): guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 2022
Subject(s):
Compassionate Use Trials -- legislation & jurisprudence
COVID-19
Device Approval -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4445. 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

4448. 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

4449. 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

4450. 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