The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has released a draft guidance document — and is seeking comments — on how real-world data (RWD) collected from outside the clinical trial process, such as information found in registries, databases, case reports, claims data, and electronic health records (EHRs), should be used when making pre- and postmarket decisions for medical devices.
The draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, is a “cornerstone of our strategic priority of creating a national evaluation system for medical devices,” the FDA wrote in an email. “That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.”
The use of RWD, and the real-world evidence (RWE) derived from aggregating it, can help improve the understanding of medical device risks and benefits, the guidance said, and is part of the FDA’s efforts to balance safety with the availability of new device technology. However, data collected from clinical environments may not have the same data quality controls as clinical trials. To that end, the FDA said it will assess the “relevance and reliability” of the data source to determine whether it is “reliable, complete, consistent, accurate, and contains all critical data elements necessary for evaluating the performance of a device in the applied regulatory context.”
Real-world data and evidence could potentially be used to:
•Generate hypotheses for future clinical studies.
•Serve as a control group.
•Collect data related to a clinical study to support device approval or clearance.
•Expand the labeling of a device.
•Support public health surveillance.
•Conduct post-approval studies.
•Replace the need for submitting an individual Medical Device Report.
•Provide postmarket data instead of some premarket data under the Expedited Access Pathway program.
The FDA said the new guidance will not change its standards for making regulatory decisions. However, the FDA said it will “consider the use of RWE to support regulatory decision-making for medical devices when it concludes that the clinical data contained within RWD sources(s) used to generate the RWE are of sufficient quality to provide confidence in the analyses necessary to inform or support the regulatory decision throughout the total product life cycle. The threshold for sufficient quality will depend on the specific regulatory use of the evidence.”
Marilyn Neder Flack, vice president of patient safety initiatives and executive director of the AAMI Foundation, said she’s pleased that the draft guidance includes the flexibility to determine when real-world data should be used, given the benefits and risks for a particular device.
“In a world of rapidly evolving technology and device software, I am excited to see FDA establishing guidance that may help great technology and enhancements to that technology get into the marketplace as safely and as quickly as possible so patients may benefit,” Flack said. “This guidance also enables companies to possibly more quickly respond to postmarket questions of safety that sometimes occur after devices are in widespread clinical use. FDA is really making great use of all data, not just clinical trial data, which comes from sources that meet the criteria outlined in the guidance.”
FDA Commissioner Robert Califf said in May that the use of real-world evidence for decisions is a “top programmatic priority” for the FDA, according to the Regulatory Affairs Professionals Society. In July, he and CDRH Director Shuren called for the use of data from registries, claims, electronic health records to support the evaluation of medical devices, in a commentary published in the Journal of the American Medical Association.
“By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices,” Califf and Shuren wrote.
Comments can be submitted online at www.regulations.gov until Oct. 25.