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Summary of FDA New PMS Guidance Under Section 522

Post-market surveillance (PMS) is an 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.

Section 522(a) (1) (A) of FD&C act specifies that the agency may issue a post-market surveillance order at the time of device approval or clearance or any time thereafter. Section 522 of FD&C act, 21 U.S.C. 360l, authorizes FDA to require post-market surveillance.