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Start Over Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Languages English ✖Remove constraint Languages: English

222. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

224. Enforcement policy for sterilizers, disinfectant devices, and air purifiers during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 2020
Subject(s):
Air Filters
Coronavirus Infections -- epidemiology
Disinfection -- instrumentation
Pandemics
Sterilization -- instrumentation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

225. Enforcement policy for gowns, other apparel, and gloves during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Personal Protective Equipment -- supply & distribution
Surgical Attire -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

226. Enforcement policy for ventilators and accessories and other respiratory devices during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Center for Devices and Radiological Health, March 2020
Subject(s):
Coronavirus Infections -- epidemiology
Pandemics
Ventilators, Mechanical -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

227. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

230. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.