Search

661. Uncomplicated urinary tract infections: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2019

Subject(s):

Clinical Trials as Topic
Drug Development
Urinary Tract Infections -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

662. Unique Device Identification System: form and content of the unique device identifier (UDI) : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, July 7, 2021

Subject(s):

Equipment and Supplies
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

663. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, April 26, 2019

Subject(s):

Equipment and Supplies -- standards
Product Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

664. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2017

Subject(s):

Equipment and Supplies -- standards
Equipment Reuse -- standards
Product Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

665. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 16, 2018

Subject(s):

Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

666. Unique device identification: policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marking : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, July 1, 2020

Subject(s):

Equipment and Supplies -- standards
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

667. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020

Subject(s):

Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

668. Use of certified health IT and methods to enable interoperability by U.S. non-federal acute care hospitals: 2019

Author(s):

Johnson, Christian, MPH (based on t.p. from bib 9918317680206676), author
Pylypchuk, Yuriy, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, February 2021

Subject(s):

Electronic Health Records
Health Information Interoperability -- trends
Hospitals
Information Dissemination
Health Information Interoperability -- legislation & jurisprudence
United States
United States. Department of Health and Human Services

669. Use of electronic health record data in clinical investigations

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2018

Subject(s):

Clinical Trials as Topic
Electronic Health Records -- statistics & numerical data
Health Information Interoperability
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

670. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018

Subject(s):

Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration