FDA User Fees

FDA announced that they are opening the floor for comments on the medical device user fee program known as MDUFMA.  MDUFMA has a 5-year lifespan and is set to expire September 30, 2012.  User fees are paid to FDA by the sponsor, or submitter, for the review of medical device premarket applications, reports, supplements, and premarket notification submissions.  This was a provision to an agreement that, provided these additional resources,  it would make FDA reviews more timely, predictable, and transparent to applicants. The ultimate goal was to approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community, and most importantly, patients.  However, industry doesn’t necessarily feel that FDA has upheld their end of the bargain.  The meeting to be held September 14, 2010 will be to hear industry’s comments on the program.  I attended a MITA meeting this week where we discussed the dissatisfaction with the current MDUFMA program.  MITA intends to provide feedback to FDA on how the program can be improved, including ways CDRH should be held accountable.  Based on the reports released this week, it seems that CDRH is going to require a lot more money to follow through on the recommendations made in the reports = higher user fee payments by industry.  How high will the payments go?  Let’s just hope they stay out of the drug user fee payment ball park!

Back to the Blog