The review criteria for medical device registration with the US FDA depend on the device classification (Class I, II, or III) and the type of submission (e.g., 510(k), Premarket Approval (PMA)). The main review criteria include:
Device Classification and Risk Assessment:
Substantial Equivalence (for 510(k) submissions):
Safety and Effectiveness (for PMA submissions):
Compliance with FDA Regulations:
Device Labeling and Instructions for Use (IFU):
Risk Management and Hazard Analysis:
Post-Market Surveillance and Reporting:
Clinical Data (if applicable):
Environmental Impact (for certain devices):
Financial Disclosures:
The FDA uses these criteria to ensure that medical devices are safe, effective, and manufactured according to the required standards before they are allowed to be marketed in the United States.
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