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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