Regulatory and Compliance
Dec 17, 2014
Complaints that FDA’s busiest pathway to market for medical devices is anything but straight piled up in 2014. By Jim Dickinson Looking back, 2014 will...
Dec 15, 2014
By Cynthia Nolte, Sandra White, and Vicki Anastasi As another year draws to a close, several guidance documents released by FDA in 2014 should be on every...
Dec 02, 2014
By Jeffrey N. Gibbs, Allyson B. Mullen, and Melissa Walker The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In...
Nov 21, 2014
During design verification, how many samples should you use for testing? A consultant answers the question. In the “MyQuickConsult Question Grab Bag,...
Nov 18, 2014
By Jim Dickinson Legacy 510(k)-cleared devices that are being modified and require a new 510(k) submission will need to be evaluated for cybersecurity risks,...
Nov 13, 2014
The third edition of the Registries for Evaluating Patient Outcomes: A User’s Guide includes a new chapter dedicated to medical device...
Oct 31, 2014
By Jim Dickinson Is there such a thing as a “grandfathered” medical device? The term means a device that was on the market before the 1976 Medical...
Oct 30, 2014
  Oxford Peformance Materials has received two 510(k) clearances for its novel and groundbreaking 3-D printed facial and cranial implants in the last 20...
Oct 27, 2014
   The TactiCath Quartz AF System St. Jude Medical announced Monday that the Food and Drug Administration has approved its TactiCath force-...
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...