The Food and Drug Administration (FDA) has issued new draft guidance, 'Predetermined Change Control Plans for Medical Devices,' which expands the allowance of Predetermined Change Control Plans (PCCPs) to all medical devices. This contrasts with previous guidance that limited PCCPs to artificial intelligence/machine learning-enabled devices.
By including a PCCP in a marketing submission, manufacturers can prospectively specify and seek premarket authorization for intended modifications without needing to submit additional marketing submissions or obtain further FDA authorization. This streamlines the process for implementing postmarket changes, such as adding new wireless cards or upgrading operating systems.
The draft guidance outlines that PCCPs should include a 'change protocol' detailing modifications, a 'modification protocol' for assessment, and an 'acceptance criteria' for evaluating changes. Exponent's expertise in medical device engineering, risk assessment, and regulatory compliance positions it to assist manufacturers in developing and implementing these complex plans.
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