Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Michael Causey

FDA Compliance

FDA and EU Spar on Medical Device Regulation

Just paying attention, says FDA; that’s hypervigilence, counters EU

Published: Tuesday, May 1, 2012 - 11:43

Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

They apparently aren’t happy that the Food and Drug Administration (FDA) is writing internal reports and making public remarks saying medical devices, especially high-risk ones, aren’t regulated so well in Europe, according to an internal report quoted in the Star Tribune and also reported over at the Regulatory Affairs Professional Society (RAPS).

British attorney Paul Ranson told me (with that accent) that the European Union generally thinks it is already doing a nice job regulating medical devices, thank you very much.

Paul Ranson

“Not in a self-congratulatory way, but I think the sense in the European Union is that they are doing it very well,” Ranson says. And while it’s not the British way to brag, he also allowed that the European Union is working on revising its medical device regulations now in an attempt to improve harmonization and centralization, among other issues.

But he called these changes—expected to be unveiled this summer—to be more like “tweaks and not revolutionary” changes.

“The intention behind the revisions is to improve and strengthen the directives and to meet growing expectations of European citizens,” Ranson says. “The current directives do not offer a uniform level of protection of public health in the European Union and new and emerging technologies have challenged the current directives. In addition, the revisions aim to simplify the directives, delivering a transparent system whereby citizens can be confident in the safety of medical devices.”

As noted in the RAPS piece, EU officials have fired back at FDA personnel who’ve disparaged their regulatory regime.

As I and others have written elsewhere, many in the medical device industry wish the FDA would take some pages from the EU’s regulatory book. Or put another way, the medical device industry wishes the FDA would cut out a lot of the pages in its long regulatory book and adapt more to the relatively streamlined approach in the European Union.

I don’t care what anyone says. I’m going to have some Freedom fries for lunch tomorrow and wash it down with some sparkling San Pelligrino water while reading my favorite Graham Greene novel.

This article first appeared in the April 26, 2012, issue of the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.