Real-World Evidence for Medical Device Regulatory Decision-Making

As health data continues to become increasingly available, opportunities are arising for the use of data to support medical device decision making. FDA has recognized this and is creating new paradigms to use real-world data (RWD) to support regulatory decision-making for medical devices.

RWD sources such as registries, EHRs, and administrative healthcare claims databases provide information relating to patients’ health status and/or the delivery of health care that is routinely collected. RWD may be used as real-world evidence (RWE) to support a variety of FDA decisions. Examples of uses include post-market studies, expanding indications, control groups, supplementary data, and objective performance criteria and performance goals.

The key to using RWD, which may become RWE, is to ensure the reliability of the data. FDA suggests two aspects to consider: data accrual methods and data quality control assurance. FDA will consider the reliability of the data before using it to inform decisions.

To learn more, feel free to read the FDA guidance document: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical devices. Or feel free to contact one of our knowledgeable consultants at KAS.