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.
Topics covered in this Whitepaper include:
- Better understand the nature, severity, or frequency of suspected problems reported in adverse event reports
- Obtain more information on device performance associated with real-world clinical practice
- Address long term or infrequent safety and effectiveness issues for implantable and other devices
- Define the association between problems and devices when unexpected or unexplained serious adverse events occur
