Medical Device News
AdvaMed: MDUFA Agreement Could Be “Game Changer” for FDA, Industry
A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said.
Posted on 3 February 2012 | 3:30 pm
Delays in MDUFA Agreement Threaten Omnibus User Fee Bill
Rather than breaking device user fees out of an omnibus bill, House Energy & Commerce Health Subcommittee Chair Joe Pitts (R-Pa.) reportedly has threatened to freeze device fees at current levels for five years if the FDA and industry can’t speed up an agreement on Medical Device User Fee Act (MDUFA) reauthorization.
Posted on 3 February 2012 | 3:30 pm
GAO: Lack of Transparency in Hospital Device Purchasing
Hospitals may be overpaying for implantable medical devices and passing those costs on to Medicare, but it is impossible to know for certain because Medicare doesn’t track device prices or what hospitals pay for them, a Government Accountability Office (GAO) report concludes.
Posted on 3 February 2012 | 3:30 pm
Fired FDAers Sue for Email Monitoring: Senator Moves for Probe of FDA
A lawsuit that charges the FDA with monitoring the personal email of former CDRH employees has sparked a congressional probe and prompted fears among legal experts, who say the FDA’s actions could have a chilling effect on other whistleblowers.
Posted on 3 February 2012 | 3:30 pm
Devicemakers May Have Some Protection in Reprocessed Failures
Manufacturers whose devices are reprocessed and later cause injury may have some liability protection, a recent federal court case evaluated by the Washington Legal Foundation (WLF) suggests.
Posted on 3 February 2012 | 3:30 pm
Heart Valve Replacement Results Improve in Ongoing TAVR Trial
Strong clinical trial results from an add-on study of Edwards Lifesciences’ Sapien transcatheter aortic valve replacement (TAVR) bode well for the company and the fledgling TAVR segment generally, analysts say.
Posted on 3 February 2012 | 3:30 pm
FDA Outlines Steps to Improve Public Access to Compliance Data
Speeding data disclosure is just one of eight proposals FDA Commissioner Margaret Hamburg is adopting as part of efforts to improve public access to compliance and enforcement data.
Posted on 3 February 2012 | 3:30 pm
Bill Could Bar Devices Tied to Unsafe Predicates
Devicemakers could have a more limited body of predicates to use in submitting 510(k) applications under legislation now before the House Committee on Energy and Commerce.
Posted on 3 February 2012 | 3:30 pm
OIG to HHS: Flex Muscle to Curb Off-Label Promotion
Devicemakers could see a stronger crackdown on off-label promotion, according to a new Office of Inspector General (OIG) report that directs HHS to focus on the practice.
Posted on 3 February 2012 | 3:30 pm
Canadian Guidance Seeks Increased Number of Women in Clinical Trials
An updated Health Canada guidance provides advice on when to include or exclude women from device and drug trials, including women who are pregnant or breastfeeding.
Posted on 3 February 2012 | 3:30 pm
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