Posted on February 3, 2012 - 4:06PM
The heated debate concerning the reauthorization of the Medical Device User Fees that has had the medical device industry on the edge of its seat for more than a year may finally be winding down. FDA announced this week that it had reached an agreement 'in principle' with industry that would allow FDA to collect higher user fees of $595 million over five years in exchange for new goals for time frames for PMA and 510(k) submissions. On the heels of this news, House Democrats introduced a bill that would close a loophole in the 510(k) clearance process associated with safety recalls. Adding to the flurry of activity, a bipartisan bill was also introduced this week that aims to streamline the regulatory pathway for medical devices to promote innovation. Read about these and other medtech highlights from the past week in our roundup below.
- FDA and Industry Reach Agreement on Medical Device User Fees (Qmed)
- Democrats Want to Let FDA Block Medical Devices Tied to Safety Recalls (Bloomberg)
- IRS Moves Forward with Plans to Implement Medical Device Tax (MD+DI)
- Should Patients Have Access to Implant Data? Medtronic, Boston Sci Weigh In (MPMN)
- VC Funding in Medtech Lackluster in Fourth Quarter of 2011 (MD+DI)
- Artificial Pancreas from Medtronic, Mayo Clinic, J&J Set to Revolutionize Diabetes Treatment Market (Qmed)
- Why Doctors Need to Embrace Their Digital Future Now (Wired)
- FDA Staffers Sue Agency Over Surveillance of Personal E-Mail (Washington Post)
- A Look at the Hurdles mHealth Designers Face this Year (MED)
- UBM Canon Introduces Medtech in an Election Year Project (medtechinsider)
- L'Affaire Pip Prompts Stress Test (EMDT)
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