FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Deve…
This final rule is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations.
This final rule is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations.
A federal district court entered a consent decree against Philips Respironics. The consent decree includes key provisions aimed to prioritize patient relief and ensure the company’s regulatory compliance.
The FDA is providing an update on its evaluation of plastic syringes made in China for device failure and announcing additional recommendations and actions the FDA is taking to address these issues.