FDA-cleared or approved test system

FDA-cleared or approved test system means a test system cleared or approved by the FDA through the premarket notification (510) or premarket approval (PMA) process for in-vitro diagnostic use. Unless otherwise stated, this includes test systems exempt from FDA premarket clearance or approval.

Source

42 CFR § 493.2

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Scoping language

As used in this part, unless the context indicates otherwise

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