Regulatory and Compliance
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By Jim Dickinson Three trade groups have found fault with FDA's draft guidance on reporting of computational modeling studies in medical submissions, which...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...
Aug 05, 2014
The Center for Drug Evaluation and Research regulates advertising and promotion of drugs more strenuously than CDRH regulates devices. Maybe it's time for a...
Aug 04, 2014
Medical device PMAs are being approved twice as fast in 2014 compared with 2013. CDRH approved 17 PMAs in the first half of 2014—almost twice as many as...
Jul 23, 2014
Earlier this month the Centers for Medicare and Medicaid Services released four new proposals to amend portions of the Sunshine Act. There are four proposed...
Jul 22, 2014
The medical device industry loves to beat up on FDA, but one person you won’t find lining up to take a shot at the agency is medtech inventor and...
Jul 14, 2014
Most medical device companies try hard to be good citizens and do their best to comply with FDA’s Byzantine regulations and policies. To varying degrees...