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Compliance In Focus
Posted by John Lehmann on Tue, Sep 4, 2012

Is FDA Breaking Down the Brick Wall for Devices?

 “One reason I think it’s going to change is we’re starting to see change already.” This statementFDA breaking down brick wall was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

As the author of the article points out, “Folks inside the industry acknowledge the FDA often is caught between a rock, a hard place and an anvil -- trying to satisfy industry advocates and patient groups that think medical devices are approved too slowly, while some consumer groups and attorneys worry that devices are hitting the market without adequate vetting.”

It’s the age old problem of finding the perfect balance. We’ve published blogs touching on both sides of the issue, such as:

As a mixture of confidence and concerns surround FDA, we’re interested to know what you’re thoughts are on this critical issue of bringing proven safe and effective devices to market and quickly as possible. We’d love to hear from you, comment below!

Photo Credit: kirberich

Topics: Medical Devices, FDA Safety and Innovation Act, Margaret Hamburg, FDA, 510(k)


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