USA in the Global Regulatory Landscape

FDA's international role

• IMDRF founding member — the US was a founding participant of the International Medical Device Regulators Forum
• Global benchmark — FDA 510(k) clearance and PMA approval are used as reference points in other countries' reliance pathways
• GMP mutual recognition — FDA has MRAs for GMP inspections with EU, Canada, and others

Quick comparison

Jurisdiction	Body	Submission	Equivalent to
USA	FDA / CDRH	510(k) / PMA / De Novo	—
Australia	TGA	ARTG inclusion	510(k) / PMA
EU	Notified body	CE marking (MDR)	510(k) / PMA
Canada	Health Canada	Device Licence	510(k) / PMA
Singapore	HSA	Product registration	510(k) / PMA

Official resources

• IMDRF
• FDA — International Programs