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.
On May 29-30, 2024, hear from FDA’s regulatory experts in medical product centers: devices, drugs, and biologics. The conference is free and offered in person and virtually. Registration is now open.
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.