Professional Integrity Heads Regulatory News in 2008
This article was originally published in RAJ Devices
The practice of companies showering doctors with gifts is on the way out in the US, the world’s biggest market for medical devices. Europe’s agency for regulating medicines could become involved in evaluating medical devices. And, again in the US, the Food and Drug Administration might raise the bar for the great many companies that use its 510(k) procedure to gain market clearance for products.