Devicemakers Say EU Approval Path Doesn’t Trump U.S. FDA Process

Taking a device to Europe to gain quicker access to market compared with the U.S. Food & Drug Administration (FDA) review mechanism is a short-term fix, not the solution to maintaining the pace of industry innovation.

“There is no replacement to the U.S. system,” said Josh Makower, CEO of device incubator ExploraMed, at the 2011 AdvaMed Medtech Conference. Going to Europe “is not going to keep this industry alive. If we don’t get the U.S. to turn itself around, there will be a global impact on innovation.”

Lately, even more than usual, American devicemakers have been criticizing the FDA for being slow and unpredictable. Companies cite lags in obtaining investigational device exemptions (IDEs) needed to start human trials.

Domestic regulatory burdens have driven two-thirds of small device companies to go first to Europe for clearance, an industry study states.

Despite years of harmonization talks, the EU and U.S. still follow very different marketing approval processes for medical devices. And when the EU’s Medical Device Directives went into effect in 2010, those differences became more pronounced.

Failing to know the differences could critically handicap your time to market and ability to operate efficiently. Failing to comply with those differences could shut you out of the markets completely.

With this new FDAnews management report, Medical Device Regulation in the EU vs. US: Recent Revisions and Key Differences, you’ll get practical guidance on exactly how recent revisions and key differences in both sets of regulations affect your market access.

Make sure you’re fully informed — and in compliance. Order this book today!