Medical devices; effective date of requirement for premarket approval for three class III preamendments devices. Final rule.
The Food and Drug Administration (FDA) is requiring the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
D001784:Blood Gas Analysis / Q000295:instrumentation*; D002315:Cardiopulmonary Bypass / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D010991:Plethysmography / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration