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Established in 1973, the Association of Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade association that serves as a resource for education and information on compliance issues between member companies, and as an interface between member companies and the FDA. Today membership includes companies of all sizes who manufacture and distributenbsp; in vitro diagnostic products, including cell cultures and cell culture media, immunology and immune status test products, antigen and microbial detection products, and toxicology. 
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    "It is the purpose of this organization to raise the standards of excellence, now prevailing, to even higher levels.  To attain this goal, we propose the free exchange of technical information among members of the industry and mutual assistance in the formulation of, and compliance with, regulatory legislation standards and protocols."
AMDM Articles of Incorporation, 1973 

 

 
Communication with members
  • We provide members with FDA directives and guidance documents. 
  • We provide information to members on international regulations and guidelines. 
  • We publish a comprehensive newsletter to keep members informed of regulatory issues. 
  • We provide two meetings each year.
Liason between members and Regulatory Agencies
  • We meet with the FDA and other regulatory agencies acting as a liaison for our members and the FDA through our legal counsel. 
  • We take issues common to our members directly to the FDA administration. 
Member education
  • We educate members on compliance issues, manufacturing practices, regulatory issues, and quality issues. 
  • We advise and train members in: Validation Methods, Staff Training, Manufacturing Process Control, Documentation, ISO 9000 international quality standards, Product Submissions, and GMP Interpretations.
  • We provide opportunities for members to network and benchmark.
Part of the solution
  • We lobby for FDA reform legislation. 
  • We are active in organizations which set guidelines for our industry. 

 

 Food and Drug Administration (FDA)
  • GMP Advisory Panel
  • Microbiology Panel
  • 510K/PMA Guidelines
  • Preproduction Quality Assurance
  • Import/Export Issues
  • Immunology Panel
  • GMP Guidelines for IVD Products
  • IVD Labeling Requirements
  • Device Experience Reporting Regulations

  Health Care Financing Administration (HCFA)

  • Clinical Laboratory Improvement Amendment

  Occupational Safety and Health Administration (OSHA)

  • Employee Right to Know Regulations
  • Occupational Exposure to Blood-Borne Pathogens
  • Laboratory Worker Safety Issues

  Environmental Protection Agency (EPA)

  • Infectious Waste Issues
  • Hazardous Waste Issues

  U.S. Department of Agriculture (USDA)

  • Import/Export Regulations
  • Animal Welfare Compliance Issues

 

 National Committee for Clinical Laboratory Standards
  • Subcommittee on Culture Media
  • Subcommittee on the Standardization of Fetal Bovine Serum
  • Subcommittee on Antimicrobial Susceptibility Testing
  • Subcommittee on Veterinary Anitmicrobial Susceptibility Testing

  ISO Technical Committees

  • ISO/TC 210-Quality Management and Corresponding General Aspects for Medical Devices
  • ISO/TC 212-Clinical and Laboratory Testing and in vitro Diagnostic Test Substances