Regulatory and Compliance
Oct 09, 2014
CDRH has heard the medical device industry’s grumblings about its refuse-to-accept policy for premarket notification submissions and plans to make some...
Oct 02, 2014
By Jim Dickinson   A Washington, DC, federal judge has dismissed a civil lawsuit by current and former CDRH whistleblowers because they failed to exhaust...
Sep 30, 2014
By Jim Dickinson FDA conducted 3% fewer medical device quality system surveillance inspections last year than in 2012. Just-released device inspection results...
Sep 30, 2014
By Jim Dickinson If your company is among the recipients of more than 100 letters from CDRH rescinding a marketing clearance under Sec. 510(k) of the Food...
Sep 17, 2014
By Jim Dickinson Three years after its first try, FDA on September 15 took a second swipe at down-classifying external pacemaker pulse generator devices from...
Sep 02, 2014
By Jim Dickinson CDRH Office of Device Evaluation (ODE) director Christy Foreman is stepping down effective September 7, 2014, to accept a new position as...
Sep 02, 2014
By Jim Dickinson FDA’s oft-criticized 20-year-old, lumbering, and frequently ignored adverse event database for medical devices is getting a new lease...
Sep 02, 2014
By Jim Dickinson FDA is soliciting proposals for participation in a medical device development tools (MDDT) qualification pilot program under which the agency...
Sep 02, 2014
By Jim Dickinson Medical technology industry trade association AdvaMed says it is “gravely concerned regarding the wide-ranging impact” of a...
Aug 28, 2014
By Jim Dickinson   Several advocacy groups are voicing strong support for a proposed FDA order to reclassify surgical mesh used to repair transvaginal...