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4. Postmarket Surveillance Studies — The FDA may order a manufacturer of certain Class II or Class III devices to conduct postmarket surveillance studies (often referred to as “522 studies”).3 Study approaches vary widely and may include non-clinical device testing, analysis of existing clinical databases, observational studies, and, rarely, randomized controlled trials. Status updates for ongoing postmarket surveillance studies covering approximately a dozen device types may be found on our website at http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pss.cfm.

5. FDA Discretionary Studies — In addition to medical device adverse event reports, post-approval and postmarket surveillance studies, the FDA also conducts its own research to monitor device performance, investigate adverse event signals and characterize device-associated benefits and risks to patient sub-populations. A variety of privacy-protected data sources are used including national registries, Medicare and Medicaid administrative and claims data, data from integrated health systems, electronic health records, and published scientific literature.