FDA recently issued new final guidance for medical device manufacturers navigating the premarket approval (PMA) and de novo decision pathways. The document, entitled Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications was issued on March 28, 2012 and describes in detail how FDA will weigh the risks and benefits of a device during premarket review—both in the future and for devices currently under review.
Featured in the guidance is a worksheet designed to streamline the risk-benefit analysis of submissions by providing in advance several key features of the device’s potential to do both harm and good, including: the duration, type, and magnitude of risks and benefits; as well as risk likelihood, patient tolerance, reported value to patients, and available alternatives. According to the guidance introduction, “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.”
For more information about the premarket process or for help with premarket device strategy, planning, and submissions, contact Pearl.