Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff.

摘要

This guidance clarifies the Food and Drug Administration’s (FDA or the Agency) current policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval while still meeting the statutory standard of reasonable assurance of safety and effectiveness. The right balance of premarket and postmarket data collection facilitates timely patient access to important new technology without undermining patient safety. FDA believes this guidance document will improve patient access to safe and effective medical devices that are important to the public health by improving the predictability, consistency, transparency, and efficiency of the premarket review process. This guidance document is intended to support FDA’s efforts to enhance timely availability of devices subject to premarket approval. This guidance describes FDA’s existing statutory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), its implementing regulations, and current policies that support this policy. In addition, FDA clarifies how FDA considers postmarket data as part of the benefit-risk framework described in FDA’s guidance, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” issued on March 28, 2012 (“Benefit-Risk Guidance”).2 This guidance and FDA’s guidance “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need,”3 issued on April 13, 2015 (“EAP Guidance”) describe how FDA considers balancing premarket and postmarket data collection during review of a PMA. FDA’s guidance documents, including this one, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.