References

FDA FURLS – FDA Establishment and device listing

FDA DFUF – FDA payments

FDA Device Advice – Educational site run by the FDA for medical device companies

CDRH Learn – FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education

FDA 510(k) database – The database of all 510(k) submissions

FDA 21CFR search – The search tool for the Code of Federal Regulations section 21

93/42/EC MDD – European Medical Device Directive

ICH - The International Conference on Harmonization guidelines on clinical studies

EMA – European Medicines Agency

ISO – International Standards Organization (standards for purchase)

AAMI - Association of Medical Instrumentation (standards for purchase)

RAPS – Regulatory Affairs Professional Society educational material for purchase

EU Directives – Medical Device European regulations

FDA Guidance Documents – Medical Device regulations for the United States

90/385/EC AIMDD – European Active Implantable Medical Device Directive

98/79/EC IVDMDD – European In Vitro Diagnostic Medical Device Directive

MEDDEV – Guidelines relating to medical device Directives

NB-MED – The European Association for Medical devices of Notified Bodies

NBOG – Notified Body Operations Group (NBOG)

FDA Recognized Standards – FDA recognition of international medical device consensus standards

EU Countries - List of member states in the European Union

Notified Bodies

BSI – British Standards Institution

TÜV SÜD America – Technical Monitoring Association

LNE/G-MED – National Metrology and Testing Laboratory (LNE)

NSAI – National Standards Authority of Ireland

EU Representative

MDSS – Medical Device Safety Service

Donawa Lifescience Consulting

Testing

Nelson – Provider of full, life-cycle microbiology testing services

Intertek – Network of electrical testing laboratories

Nemko –Electrical testing and certification