FDAnews Device Daily Bulletin
Sept. 27, 2012 | Vol. 9 No. 190
The FDA is giving devicemakers an additional 45 days to comment on the collection of information associated with a unique device identifier (UDI) system.
FDA officials sounded a familiar drumbeat during an Aug. 27 meeting on ways to notify the agency about changes to PMA products, asking devicemakers to submit more complete information upfront to ensure their submissions can be processed quickly.
More seniors are getting their knees replaced with artificial joints, according to a new study of Medicare data.
Stryker said it expanded the recall of its Neptune surgical waste management product line to include later versions because U.S. health authorities have advised the company that these devices do not have proper regulatory clearance.
The European Union said it wants tougher rules governing the safety and monitoring of medical devices after weak EU regulations were partly blamed for a global scandal over French-made breast implants.
Today, patients with chronic lung conditions such as cystic fibrosis or asthma can’t easily monitor how their airways are doing.
A diagnostic device could speed up and take the guesswork out of diagnosing and guiding treatment for excessive bleeding and overactive clotting in clinical settings.
McKesson plans to build a $36.9 million distribution center in Frederick County, Va., for its Medical-Surgical division.
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