Regulatory/Legal
Nov 18, 2015
A number of medical devices have come under fire this year, but FDA doesn't have "imminent hazard" authority to take a device off the market....
Nov 13, 2015
An FDA inspection can be nerve-wracking. Learn what two experts say you can do in person during an inspection to avoid receiving Form 483 observations or a...
Oct 23, 2015
FDA interest in involving public and private payers early in the review process may be very beneficial to medical device makers. Yarmela Pavlovic and Beth...
Oct 22, 2015
Regulatory affairs professionals have the mounting pressures of revised regulations, more PMAs, IDEs, and change requests to contend with, but don't have...
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 ...