FDA tightens rules on radiation-emitting therapeutic devices
April 8, 2010 by MassDevice staff
The Food & Drug Administration says it received nearly 1,200 reports involving radiation therapy used to fight cancer; FDA director of in vitro diagnostic device evaluation and safety Alberto Gutierrez says no new devices will be cleared using third-party reviewers or the special 510(k) process.
The Food & Drug Administration is looking to cut down on the number of accidental radiation overdoses by changing the way new radiation-emitting therapies make it to market.
The federal watchdog agency sent out a letter to manufacturers today, reporting that it received 1,200 reports between 1999 and 2010 about devices that deliver radiation treatments to cancer patients.
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Medical Device Tax: Are Conservatives' goals hampering repeal efforts?
- Personal health record use by adolescents
- Can Johnson & Johnson fire on all cylinders again?
- U.S. FDA to require proof of IEC 60601-1 3rd Edition in summer 2013
- A cure for coffee breath?
- A Goldilocks approach to leaky blood vessels: Not too stiff, but not too loose
- Optimizing electronic medication administration records
- A bold new vision for Meditech
- Medtech storytelling in the era of comparative effectiveness
- Medical device sales: Wright Medical's pilot program on rep-less sales process worth watching
Navigation
NEWS
Breast cancer: Hologic wins FDA approval for new mammography software
Hologic wins FDA approval for its new C-View 2D imaging software for use with its 3D breast...
BRIC house of cards? Emerging markets aren't delivering on healthcare
The hallowed emerging markets in Brazil, Russia, India and China aren't generating the kind of growth...
FDA approves Bausch + Lomb's eye implant
Medical device company Bausch + Lomb won FDA approval for its Trulign Toric intraocular lens, the 1st...
Claret Medical's filter thwarts debris headed for the brain in TAVI patients, study shows
California medical device maker Claret Medical's embolic protection technology captures debris...
Report: Galt Medical's Texas plant closure means 139 layoffs
Texas-based Galt Medical Corp. is reportedly laying off 139 workers as it shutters its hometown plant...
