EU Parliament: No PMAs here please
The European Parliament today votes not to require medical devices to undergo an approval process akin to that required by the FDA's pre-market approval program.
The European Parliament today failed to back an EU panel's recommendation to enact strict requirements for medical device approvals that would have matched those required by the FDA's pre-market approval program.
The EU body voted instead to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the "notified bodies" that govern medical device regulation there.
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