We have written many blogs on the medical device tax and thought we have covered almost angle on this issue.  However, we thought this article in FierceMedicalDevices brought a new strategic twist to the discussion. There has been a concerted effort by the industry to repeal the 2.3% medical device revenue since it was introduced in the Affordable Care Act.

That is the burning question asked at last week’s OneMedForum in San Francisco.  Facing a tight funding climate, price pressure and the new medical device tax, the medical device is facing a very tough business environment.  As Stephen Ubl, AdvaMed president and CEO stated, “It has probably never been harder to bring a device from bench to bedside.”

While the goal was for FDA to develop the proposed Unique Identification Rule in close collaboration with the clinical community, patient and consumer groups, and with the data from four pilot studies- is it possible FDA missed the mark? According to the industry group The Advanced Medical Technology Association (AdvaMed) changes need to be made to the agency’s rule to make it useful, cost-effective and practical.

Like most new pieces of legislation, the FDA user fee deal, signed into law by President Barack Obama in July provides medical device companies with both challenges and opportunities.

Discussion on the FDA’s 510(k) program remains a very popular topic.  According to an article in MD+DI, industry groups are urging major changes on the FDA’s draft on evaluating substantial equivalence in 510(k)s.  Not surprisingly, Public Citizens is asking the agency to delay the guidance because they feel it’s overly permissive.

The tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act (MDUFMA) is long awaited good news! IMARC covered the story of how the FDA missed the MDUFMA proposed deadline, January 15th, in a previous blog. But, luckily it looks like the medical device industry and the FDA were able to find common ground.