Regulatory/Legal
Feb 11, 2016
In a new report, Public Citizen rails against a legislative proposal in the 21st Century Cures Act that would encourage FDA to approve high-risk medical...
Feb 01, 2016
Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know. Zhenghong Tao, Laurence...
Jan 25, 2016
What's in a name? A lot, when it comes to naming your new medical device. Here is an expert's advice on trademarks for medtech companies. Josh Gerben...
Jan 19, 2016
CDRH unveils its "patient power" initiative at the same time that a third patients' group rallies against the Center's medical device safety...
Dec 15, 2015
A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and...
Dec 07, 2015
Thinking of entering the Chinese medical device market in 2016? A life sciences regulatory expert details trends you need to know, like localization and...
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...