US Aortic Valve Registration Requirements
B) False - US registration of an aortic valve requires FDA approval only, not CE certification.
Regulatory Framework
In the United States, medical device approval is governed exclusively by the FDA, and CE marking is not required for US market authorization. 1 The FDA operates independently from European regulatory bodies, and devices must meet FDA-specific requirements regardless of their CE mark status. 2
Key Regulatory Distinctions
FDA vs. CE Mark
- FDA approval is mandatory for any medical device, including aortic valves, to be marketed in the United States 1
- CE marking is a European regulatory requirement that allows devices to be marketed in the European Economic Area 2
- These are separate, independent regulatory pathways - obtaining one does not fulfill the requirements of the other 2
Historical Context for Aortic Valves
The evidence demonstrates this separation clearly:
- The Edwards SAPIEN valve and Medtronic CoreValve both received CE mark approval in Europe in 2007 3
- However, these same valves required separate FDA approval processes for use in the United States, including the PARTNER trial for the SAPIEN valve 3
- The CoreValve underwent its own independent US randomized multicenter trial for FDA evaluation 3
US Approval Process for Aortic Valves
Transcatheter aortic valves in the US traditionally require randomized clinical trials for FDA approval, which is a more stringent requirement than the CE mark process. 3 The FDA has historically required:
- Premarket approval (PMA) with clinical trial data for high-risk devices 1
- More recently, some new-generation valves have been approved based on single-arm studies with objective performance criteria 3
Common Pitfall
Do not confuse international marketing strategy with regulatory requirements. While manufacturers often pursue both FDA and CE mark approvals to access multiple markets, this reflects business strategy, not a US regulatory mandate requiring both certifications. 2