What is FDA’s Role?
The Food and Drug Administration (FDA) protects the public’s health by ensuring the safety, efficacy, and security of medical devices and promoting public health by supporting innovations that make medical devices more effective, safer, more affordable, and helping the public utilize science-based information to improve their health. The FDA participates on the MDIAS Governing Committee with other industry representatives and contributes as an equal partner with industry and providers, adhering to all MDIAS policies and procedures. As appropriate, FDA may provide data for MDIAS studies. The FDA does not see non-public data that is shared with the Trusted Third Party from other participants. The FDA supports the voluntary collaboration to share and analyze data to improve healthcare outcomes by strengthening overall medical device quality and patient safety.
Did You Know?
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting public health with a specific focus on medical devices and radiating-emitting devices. The CDRH facilitates medical device innovation by promoting and supporting research utilizing data from across the medical device ecosystem and making sure that consumers, patients, and their caregivers can find the information they need.
In a response to an increase in adverse events associated with medical devices, the CDRH began collecting and leveraging data from multiple sources to understand gaps in the medical device industry. By responding to issues like adverse events, recalls, complaints, and other medical device trends, the CDRH began taking steps toward launching the Case for Quality (CfQ) program – working with medical device stakeholders like manufacturers, healthcare providers, and patients – to identify and promote practices that support consistent high quality medical devices.
The MDIAS public private partnership was implemented to incorporate a data sharing and analytics partnership model to incorporate information from across the medical device ecosystem to advance medical device quality. By participating in MDIAS alongside industry partners and healthcare providers, the FDA and other MDIAS partners contribute their time, expertise, and data for aggregate analysis for studies, and benefit from having contact with others in the ecosystem to discover and address common quality and safety issues that span across health systems.