Regulatory and Compliance
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...
Aug 28, 2014
By Jim Dickinson     When a medical device firm submits a 510(k) premarket notification to FDA and then duly receives a not substantially equivalent...
Aug 07, 2014
By Jim Dickinson Three trade groups have found fault with FDA's draft guidance on reporting of computational modeling studies in medical submissions, which...
Aug 07, 2014
By Jim Dickinson Although FDA says it has issued about 100 510(k) rescission letters since this most popular market-entry program for medical devices began,...
Aug 05, 2014
Kalush A National Medical Device Curriculum is using fictional case studies to give students and science and technology innovators core information about the...