Washington Wrap-Up
Court Upholds FDA in Menaflex Case
May 14, 2013
FDA acted properly and within its statutory authority when it reclassified ReGen Biologics Menaflex knee repair device and rescinded the company’s 510(k...
Guidance on Device Classification Product Codes
May 14, 2013
 FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current...
Share Intellectual Property, Ex-FDA Chief Says
May 08, 2013
Former FDA commissioner Andrew von Eschenbach thinks medical device and diagnostic companies should be collaborating and sharing intellectual property to...
CDRH Ponders Ways IDEs Can Boost Innovation
May 08, 2013
CDRH is considering how it might rebalance its evaluation of risk/benefit factors in the review process for some medical devices, according to CDRH’s...
Another Classification Kerfuffle at FDA
Apr 30, 2013
In the 2012 FDA Safety and Innovation Act enacted last summer, FDA managed to persuade Congress give it new administrative-order authority over the...
Orthofix VP Jailed for Paying Kickbacks
Apr 05, 2013
A federal judge sentenced former Orthofix sales vice president Thomas P. Guerrieri to eight months in prison. Guerrieri must also pay a fine of $20,000 and...
Stryker Sees Double Trouble from FDA
Apr 03, 2013
On two scores, Fortune's World’s Most Admired Companies 2012 listee (No.3) Stryker Corp. had trouble at FDA in March. Most serious, it received a...
CDRH Ombudsman Justifies Existence in Annual Report
Apr 03, 2013
The newest annual report from the CDRH ombudsman says the office received 493 new contacts in 2012, up 7% from the 461 in 2011. It breaks these down to 217...
Does Your Medical Device Really Need to be in Class III?
Mar 26, 2013
Dozens, and possibly hundreds, of Class III medical devices don’t need to be in that most stringently regulated category, says Leroy Hamilton, a former...
FDA to Require PMA for Two Metal-on-Metal Hip Replacements
Jan 31, 2013
FDA announced in January that it intends to require filing of a PMA or a notice of completion of a product development protocol for two types of metal-on-metal...