Subjects: Access to Information / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Access to Information ✖ Genre Guideline ✖

1. 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
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):: Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Access to Information
Equipment and Supplies -- standards
Health Records, Personal
Information Dissemination
Patient-Centered Care
Health Policy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.