Regulatory/Legal
Dec 02, 2016
Cook Medical Device: Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery...
Dec 02, 2016
2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the...
Nov 21, 2016
FDA's final guidance on Medical Device Reporting for Manufacturers eliminates the need to report use errors that don't result in death or serious injury. An...
Nov 18, 2016
Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to...
Nov 17, 2016
Here are ten strategies that medical device makers of all sizes can use to build a solid patent portfolio. Hyeongsu Rick Park and Ron Schoenbaum Medical...
Nov 16, 2016
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring. Jim Dickinson The last year of...
Nov 15, 2016
Medical device makers should be aware of how FDA decides to regulate wound dressings containing drugs, since that regulation is likely to be broadly applied to...
Nov 07, 2016
Who is repairing your medical devices? FDA should extend its regulatory oversight to the entities that service medical devices. Patrick Hope Who fixes your...
Oct 31, 2016
During a State of the Union lecture, CDRH director Jeffrey Shuren highlighted early wins of FDA's shift toward postmarket surveillance, novel approaches to...
Oct 24, 2016
Here's what the proposed Medical Device User Fee Amendments IV, slated to take effect in October 2017, mean for the device industry. Heather Rosecrans, FRAPS...