United States Food and Drug Administration (FDA) Launches Regulatory Reliance Portal
FDA Launches CDRH Regulatory Reliance Portal
The FDA’s Center for Devices and Radiological Health (CDRH) has launched the CDRH Regulatory Reliance Portal, a new resource for regulatory authorities interested in learning about or considering regulatory reliance for medical/dental devices. The portal centralizes existing FDA resources so regulatory authorities can more easily access useful information, including:
- An introduction to reliance and key considerations for its use
- Information on CDRH regulatory processes involved in the FDA’s medical/dental device review, decision-making, and postmarket surveillance
- Links to the FDA’s publicly available resources that regulatory authorities can use to support reliance
