<--- Back to Details
First PageDocument Content
Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Premarket approval / Validation / Design controls / Quality management system / Medical device / Food and Drug Administration / Medicine / Health
Pharmaceutical sciences
Federal Food
Drug
and Cosmetic Act
Center for Devices and Radiological Health
Premarket approval
Validation
Design controls
Quality management system
Medical device
Food and Drug Administration
Medicine
Health

Use of Standards in Substantial Equivalence Determinations

Add to Reading List

Source URL: www.fda.gov

Download Document from Source Website

File Size: 46,22 KB

Share Document on Facebook

Similar Documents

Jeffrey Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug AdministrationNew Hampshire Avenue Silver Spring, MD

Jeffrey Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug AdministrationNew Hampshire Avenue Silver Spring, MD

DocID: 1tLOR - View Document

Digital Health Innovation Action Plan  Introduction FDA’s Center for Devices and Radiological Health (CDRH) puts patients at the forefront of our vision—we are driven by timely patient access to high-quality, s

Digital Health Innovation Action Plan  Introduction FDA’s Center for Devices and Radiological Health (CDRH) puts patients at the forefront of our vision—we are driven by timely patient access to high-quality, s

DocID: 1ttzz - View Document

Post-doctoral fellow position #2 – Research Focus Nanotechnology/nanotoxicology - Safety of engineered nanomaterials The Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryl

Post-doctoral fellow position #2 – Research Focus Nanotechnology/nanotoxicology - Safety of engineered nanomaterials The Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryl

DocID: 1sM2j - View Document

Sunlamps: Regulatory Issues W. Howard Cyr, Ph.D. Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD USA  For distribution at the following meetings:

Sunlamps: Regulatory Issues W. Howard Cyr, Ph.D. Office of Science and Technology, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD USA For distribution at the following meetings:

DocID: 1srEV - View Document

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

DocID: 1rmMY - View Document