FDA Unlocks the Key to Innovation in Interoperable Medical Devices
Exeed Regulatory Compliance
FEBRUARY 25, 2020
This is a regulatory pathway for novel devices which cannot utilize an existing predicate device for 510(k) clearance, and they are not high risk to need approval through the longer PMA pathway. A quick search on the FDA consensus standards database using the keyword “interoperability” shows 32 standards.
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