1. FDA Website [www.fda.gov/patients/device-development-process/step-5-fda-post-markey-device-safety-monitoring].
2. Sentinel Initiative Website [www.sentinelinitiative.org].
3. Medical device post-approval safety monitoring: where does the United States stand?;Rajan;Circ Cardiovasc Qual Outcomes,2015
4. Post-market approval surveillance: a call for a more integrated and comprehensive approach;Mehran;Circulation,2004
5. Epidemiology: Principles and Practical Guidelines;Van Den Broek,2013