The FDA's Center for Devices and Radiological Health (CDRH) is committed to ensuring the safety and effectiveness of medical devices throughout their lifecycle. A crucial aspect of this oversight is postmarket surveillance, which involves monitoring devices after they enter the…
Advancements in digital health technologies, including artificial intelligence/machine learning-enabled medical devices (MLMD), necessitate developing regulatory expectations that are aligned with best practices for development and change management to support the quality of such devices. The change management process helps to…
On October 3, 2023, the FDA issued a proposed rule1 aimed at helping to ensure the safety and effectiveness of in vitro diagnostic products (IVDs) offered as LDTs, due to concerns that without FDA oversight false test results or false…
Medical devices that are placed inside a surgically or naturally formed cavity of the human body are considered implants by FDA.1 These can be permanent (e.g., knee implant) or temporary (e.g., chemotherapy ports), and are made from a wide variety…
