Useful Links

Food and Drug Administration

FDA Home Page
FDA Center for Devices and Radiologic Health (CDRH)
Online Search of CFR Title 21 – Food and Drugs: Parts 1 to 1499 (FDA)
CDRH Databases
Federal Food, Drug, and Cosmetic Act
Online Search of the Federal Register (GPO-FDsys)
Online Search of the Code of Federal Regulations (GPO-FDsys)
Device Advice

European Union

EU Medical Device Regulation [pdf]
Harmonized Standards for All Directives
Consolidated Medical Device Directive [pdf]
Harmonized Standards related to the Medical Device Directive
Guidelines related to the Medical Device Directive (MEDDEV)
Team NB – Notified Body Recommendations (NB-MED)
Notified Body Operations Group (NBOG)
Consolidated In Vitro Diagnostic Devices Directive [pdf]

Health Canada

Health Canada Home Page
Medical Devices
Acts and Regulations
Compliance and Enforcement/Mandatory Problem Reporting
Canadian Medical Devices Regulations [pdf]
Justice Canada

Standards

International Standards Organization (ISO)
Association for the Advancement of Medical Instrumentation (AAMI)
American National Standards Institute (ANSI)
European Committee for Electrotechnical Standardization (CENELEC)

Guidances

Online Search of FDA Guidances
International Medical Device Regulators Forum
International Conference on Harmonisation (ICH)

Blogs

FDA Law Blog – Hyman, Phelps & McNamara
Medical Device Blog
Medical Translation Blog

Professional Organizations

Regulatory Affairs Professional Society (RAPS)
American Society for Quality (ASQ)
Parenteral Drug Association (PDA)
AdvaMed
Bay Area Clinical and Regulatory Roundtable (BACRR)

Trade Magazines and Supplier Directories

Medical Device and Diagnostic Industry (MDDI)
Qmed.com
Biopharm International