Aptiv Solutions Medical Device Blog
March 12, 2012 / MEDICAL DEVICE BLOG
Rosina Robinson, Affiliate Regulatory Consultant at Aptiv Solutions, has been published in the February 2012 edition of the Journal of Medical Device Regulation (JMDR). She brings her substantial industry experience to the subject of her article, which is entitled “US FDA Medical Device User Fee Update.”
Rosina details the crossroads reached by the current medical device user fee program in the United States, which is facing a possible sunset in the fall of 2012 unless new regulations are proposed by the FDA. The article offers extensive background information concerning the genesis of the most recent medical device user fees, including an explanation of several key amendments to the Medical Device Technical Corrections Act and the Medical Device User Fee Stabilization Act. Rosina then segues into a discussion of the Medical Device User Fee and Modernization Act (MDUFMA) III, which is the label used to refer to the updates to the existing legislation within the industry and at the FDA…