This is the second alert the agency has issued in less than one year.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
The company just announced that it is restructuring its global supply chain.
For under $500, researchers have developed an open source bioprinter that they say is on par with machines costing significantly more money.