Table 1.

Comparison of device regulation in the United States and European Union

	United States	European Union
Title Granted	FDA Approval/Clearance	Conformité Européenne
Burden of Proof	Devices must demonstrate effectiveness	Devices must “function as intended”
Oversight	Manufacturer interact with single federal entity throughout process	Numerous (>70) Private groups (Notified Bodies) compete in open market for opportunity to approve devices
Marketability	Available within US	Approval by one NB allows marketability in each member country
Time of Approval	3–11 months for 510(k), 9–54 months for PMA	For 510(k) and PMA equivalents, 4 and 11 months, respectively