What are the regulatory requirements for in vitro diagnostics?
Date:2023-01-09
1. In vitro diagnostics products must comply with all applicable medical device regulations enforced by the U.S. Food and Drug Administration (FDA).
2. In vitro diagnostics must be manufactured and distributed in compliance with the Quality Systems Regulation (QSR) and Current Good Manufacturing Practice (cGMP) standards.
3. Manufacturers must participate in premarket testing and obtain the clearance or approval from FDA for all in vitro diagnostic products, for devices intended for use in the United States.
4. The manufacturer must label their in vitro diagnostic product with a label conforming to FDA requirements.
5. In order to retain the original FDA clearance or approval, manufacturers of in vitro diagnostic products must comply with the Medical Device Reporting (MDR) requirements and report any adverse events or product defects to the FDA.
6. In vitro diagnostic products must be registered with the FDA and be in compliance with FDA’s Unique Device Identification (UDI) system.
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