Regulatory/Legal
Oct 20, 2015
Even if you're at a non-Chinese company, you can still take advantage of the China Food and Drug Administration's fast track approval process for...
Oct 19, 2015
Injured patients have taken their demonstration to the email inbox of CDRH director Jeffrey Shuren. Jim Dickinson “Hey, hey FDA, how many people have...
Oct 06, 2015
Device makers will want to be aware of one sentence omitted from a proposed rule about tobacco products. Marie Thibault Unsurprisingly, MD+DI focuses mainly...
Oct 02, 2015
CDRH is getting high marks for excellent customer service, but at the same time, some stakeholders say their concerns are met with what they feel are...
Sep 28, 2015
The International Organization for Standardization has released its 2015 revision of the ISO 9001 quality standard. Check out all the major changes here. Marie...
Sep 21, 2015
Nephros Water Filtration In October 2013, a recall of the Nephros SafeSpout, SafeShower HH, and SafeShower FH was announced. According to the FDA ...
Sep 21, 2015
INRatio2 PT/INR Professional Test Strips In April 2014, Alere recalled its INRatio2 PT/INR Professional Test Strips because patients reported conflicting...
Sep 21, 2015
Tiger Paw System II A recall of Maquet Medical Systems' Tiger Paw System II was announced in March 2015 after it was found that "incomplete closure...
Sep 21, 2015
Maquet Intra-Aortic Balloon Pumps Some of the intra-aortic balloon pumps (IABP) made by Maquet Datascope Corporation were recalled in March 2014 because...
Sep 21, 2015
NaturaLyte Fresenius' NaturaLyte Liquid Bicarbonate Concentrate was recalled in April 2014 because of its potential to "develop higher than expected...