FDA In Brief: FDA issues new guidance to facilitate expanded use of real-world evidence in medical device development

Media Inquiries

"As more opportunities arise to gather reliable data from the real-world use of medical devices, there's also more opportunities to use this data to generate evidence to support the more efficient development of new innovations and inform the safe and effective use of existing products in real-world settings," said Scott Gottlieb, M.D., Commissioner of the Food and Drug Administration. "Our aim is to encourage the development and use of real world evidence gleaned from actual use by advancing these expanded recommendations for device manufacturers and the medical community. Greater use of real world evidence can help devices come to the market faster and expand the depth and reliability of the information we have to inform the safe and effective use of new products."

The FDA issued a Federal Register notice announcing the publication of a guidance titled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff." Real-world data drawn from clinical practice settings is routinely collected from a variety of sources. It can provide greater insight into the benefits and risks of medical devices, including how they’re used by health care providers and patients, and how they perform under the conditions of routine medical practice. The FDA's guidance on the use of real-world evidence clarifies how the agency evaluates real-world data to determine whether they meet the standard for use in regulatory decisions. The guidance does not change the evidentiary standards that are required to make those decisions. Real-world evidence will be critical for implementing the National Evaluation System for health Technology (NEST) that can serve as an important framework for helping to improve the efficiency of product development and improve the FDA's post market oversight.

Given the expansion in the availability and use of health data derived from registries, billing claims and electronic health records, the FDA is taking these steps to clearly describe the appropriate characteristics of real world evidence that meet the agency's standards of evidence to support regulatory decisions.

More Information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###