Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device arm, defended his agency’s performance before a U.S. House subcommittee today, rebutting a spate of recent criticism directed at the Center for Devices & Radiological Health.
The medical device industry’s public relations campaign to push the regulatory agenda its way hit another level today, with industry advocates testifying before a U.S. House subcommittee, studies taking aim at the Food & Drug Administration and even an op-ed from a pair of friendly legislators.
A House Energy and Commerce panel, the subcommittee on health, is slated to hear about the “Impact of Medical Device Regulation on Jobs and Patients” today, led by chairman Rep. Joe Pitts (R-Pa.). Med-tech industry reps will likely find a sympathetic ear in Pitts.
Johnson & Johnson issued a voluntary recall for 70,000 syringes due to cracks.
New Brunswick, N.J.-based medical products giant said the products’ labeling covers the crack site and the flaw could affect the sterility of the syringe’s contents.
The medical device industry’ s increased juice in Washington is starting to power the Beltway agenda, as Republican House leaders take note of differences between European regulatory bodies and those in the U.S. Can Congressional hearings be far behind?
Decontamination technologies maker Steris Corp. (NYSE:STE) struggles with the U.S. Food and Drug Administration continue, as the agency cited the company for making improper marketing claims about several steam-sterilization devices.
The FDA sent Steris a warning letter, dated Feb. 9, alleging that the Mentor, Ohio-based company mis-branded its devices by making claims about the devices’ capabilities that were not cleared by the FDA as part of Steris’ 510(k) applications for market clearance.
The Food & Drug Administration released a list of pre-market approvals granted in October:
January 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2011
WHIRLWIND WHEELCHAIR INTERNATIONAL510(k) NO: K103212(TRADITIONAL)
ATTN: MARC KRIZACK PHONE NO : 415 338 6277
1600 HOLLOWAY AVENUE SCI 251 SE DECISION MADE: 03-JAN-11
SAN FRANCISCO CA 94132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
DIADEXUS, INC. 510(k) NO: K101853(TRADITIONAL)
A report in the Archives of Internal Medicine is drawing a lot of buzz from its comparison of Class I recalls for devices cleared via 510(k) or via pre-market approval.
It’s time once again for the annual Beltway Budget Brouhaha and the Food & Drug Administration is wading right in with a request for a 33 percent boost.
Nearly three-quarters of Class I medical device recalls went through the Food & Drug Administration’s 510(k) pre-market notification process from 2005 to 2009, according to a report in the Archives of Internal Medicine.
That’s proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process, the authors claim, arguing that the devices should instead be reviewed via the more rigorous — and costly — pre-market approval program. Class I recalls, the most serious level, are issued for devices that could cause serious injury or death.
The plant inspection must have gone well, because the Food & Drug Administration approved Hologic Corp.’s (NSDQ:HOLX) one-of-a-kind 3d breast imaging platform, the Selenia, for performing mammograms.