Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device
This guidance document also aims to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of 522 orders, and expectations for timely study completion. Our initiative to increase transparency includes posting the manufacturers’ progress on addressing 522 orders on FDA’s website.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances 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 means that something is suggested or recommended, but not required.