The FDA has released guidance for medical device makers on the use of real-world data (RWD) and real-world evidence (RWE) in gaining approval for their products.
RWD
The “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” document was created to show how the FDA evaluates RWD and RWE. Device makers should use the guidance to understand what types of data are relevant.
In the document the FDA state that the guidance will help clarify ‘how we evaluate real-world data to determine whether it is sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices’.
Real-world data and evidence can include information collected from electronic health records, patient generated data, disease registries, clinical evidence and more.
The vast amount of real-world data that is generated is referenced by the FDA. In the document it states that the ‘FDA recognizes that a wealth of RWD covering medical device experience exists and is routinely collected in the course of treatment and management of patients.”
The FDA states that the implementation of the National Evaluation System for health Technology (NEST) to leverage RWD could ‘help to reduce the time and cost of generating the types of evidence used to support the marketing authorization of FDA-regulated products and to meet postmarket study and reporting requirements.’
NEST has been designed to combine data from different sources across the medical device industry to help ‘improve the quality of real-world evidence that health care providers and patients can use to make better informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.’
Acknowledging the potential of RWE and RWD is sure to be a boon for medical device makers looking to get their products approved. In August FDA officials wrote about the use of RWD and RWE, saying:
“Evidence linking interventions with health outcomes is the basis for good health care decision making. The widespread use of electronic health records, administrative claims, and social media and the ubiquity of smart devices have created “big data” that heretofore have not been widely utilized.”