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FDA Information

• Food and Drug Administration (FDA)
• Medical Device FDA homepage
• Device Registration and Listing Instructions
• US FDA Databases Device Classification Search
• Premarket Notification Search
• Registration and Listing
• CFR – Code of Federal Regulations Title 21
• Quality Systems Regulations

Standards Organizations

• American National Standards Institute (ANSI)
  The Institute oversees the creation and use of thousands of norms and guidelines that directly impact businesses in nearly every sector, including medical devices.
• Association for the Advancement of Medical Instrumentation
  Dedicated to increasing the understanding, safety, and efficacy of medical instrumentation.
• American Society for Testing and Materials (ASTM)
  ASTM International is a voluntary standards development organization providing a source for technical standards for materials, products, systems, and services.
• European Committee for Standardization
  CEN contributes voluntary technical standards which promote free trade, the safety of workers and consumers, environmental protection, exploitation of research and development programs, and public procurement.
• International Electrotechnical Commission
  World’s leading organization that prepares and publishes International Standards for all electrical, electronic and related technologies
• International Standards Organization (ISO)
  ISO is an international standard-setting body composed of representatives from various national standards bodies.
• National Institute for Standards and Technology (NIST)
  The NIST is a non-regulatory agency that promotes U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology.

Additional Resources

• American Society for Quality (ASQ)
• American Statistical Association
• Association of Clinical Research Professionals (ACRP)
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• International Organization for Standardization (ISO)
• Regulatory Affairs Professionals Society (RAPS)
• Society for Clinical Data Management (SCDM)