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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 devices.
The portal centralizes existing FDA resources so regulatory authorities can more easily access useful information, including:
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An introduction to reliance and key considerations for its use
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Information on CDRH regulatory processes involved in the FDA’s medical device review, decision-making, and postmarket surveillance
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Links to the FDA’s publicly available resources that regulatory authorities can use to support reliance
Questions?
If you have questions about the Regulatory Reliance Portal, please contact CDRHInternational@fda.hhs.gov.
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