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 ,
Postmarketing Surveillance Program includes the FDA Adverse Event Reporting System (FAERS); FDA may also require some MedTech companies to conduct Post-Approval Studies. 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 Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making (March 27, 2018)
• International Organization Standardization published its Clinical investigation of medical devices for human subjects — Good clinical practice, ISO 14155:2020, (July 2020)
• Medical Device Innovation Consortium (MDIC) published Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs) (August 24, 2020)
• FDA guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (September 27, 2020)
• FDA releases its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (January 12, 2021)
• Medical Device Innovation Consortium (MDIC) publish their External Evidence Methods (EEM) Framework (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, Singapore’s HSA requires real-world adverse event reporting based on the use of medical devices. Other examples include:

• South African Health Products Regulatory Authority (SAHPRA) published its Recall, Adverse Event, and Post-Marketing Vigilance Reporting of Medical Devices and IVDs in November 2019.
• In the same month, China’s NMPA issued its “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)”
• In Japan, the Ministry of Health, Labor and Welfare (MHLW) drawn up draft guidelines on the use of patient registry data in regulatory submissions for drugs and medical devices.
• The European Community passed the 2017/745 medical device regulation (MDR) 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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