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Guidance on use of real-world evidence for devices and diagnostics

Real-world evidence is often used to assess the safety of devices and diagnostics. For instance, the FDA’s ,
includes the (FAERS); FDA may also require some MedTech companies to conduct . However, as new legislation (e.g., 21st Century Cures Act) has passed and new technology has been developed, the use of real-world data is increasingly being used. Some examples include:





  • International Medical Device Regulators Forum (IMDRF) published (March 27, 2018)
  • International Organization Standardization published its , ISO 14155:2020, (July 2020)
  • Medical Device Innovation Consortium (MDIC) published Real (August 24, 2020)
  • FDA guidance (September 27, 2020)
  • FDA releases its (January 12, 2021)
  • Medical Device Innovation Consortium (MDIC) publish their (Jan 21, 2021)




Beside international and US organizations, many other countries are requiring the use of real-world evidence to monitor the safety of medical devices and diagnostics. For instance, . Other examples include:





  • South African Health Products Regulatory Authority (SAHPRA) published its in November 2019.
  • In the same month, China’s NMPA issued its “”
  • In Japan, the Ministry of Health, Labor and Welfare (MHLW) drawn up .
  • The European Community passed the which requires post-market follow-up data beginning in May 2021.




In short, regulators are increasingly requiring that safety information for medical devices and diagnostics comes not just from clinical trials, but also from real-world data.

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