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.