Tag Archives: inspection

FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).  FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017.  Notably, the reauthorized MDUFA adds a substantial new user … Continue Reading

New Study Shows Increased Enforcement Action

A new study released this week by medical device firm Emergo Group shows a steady increase in FDA inspections of medical device manufacturers since 2009.  The study showed that FDA quality system inspections between 2005 and 2009 numbered around 1500 inspections a year.  However, between 2010 and 2012, FDA averaged approximately 2000 inspections a year—about … Continue Reading