MASSDEVICE ON CALL — Mobile app developers are growing increasingly interested in healthcare, creating something of a crisis of regulation.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Valor Medical and execs plead guilty to concealing device toxicity from FDA
California biotech company Valor Medical, 4 executives and a consultant admitted to the Dept. of Justice that they concealed information about their Neucrylate diagnostic assay, hiding toxicity reports that were required as the product was undergoing FDA premarket review.
Top 3 reasons your 510(k) submission was rejected – Part II
Another Class I recall for GE Healthcare
Federal healthcare regulators put their highest-risk Class I label on a new warning issued over GE Healthcare’s (NYSE:GE) Giraffe and Panda neonatal infant warmers and resuscitation systems.
Ex-Spectranetics CEO’s conviction stands
Former Spectranetics (NSDQ:SPNC) CEO John Schulte’s 2012 conviction on a single count of lying to federal investigators survived his appeal to an appeals court, meaning his sentence of a year’s probation will stand.
Supporting innovative research through regulatory science
By: Carolyn A. Wilson, Ph.D.
FDA seeks social media surveillance
The FDA is looking to dig into social media in search of clues about public perceptions of FDA efforts and chatter that may signal an uptick in adverse events or an impending outbreak.
Medical device recalls for February 2014
February Summary
Class I recalls: 30
Class II recalls: 170
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall