4/13/2021
Photo by Bill Oxford on Unsplash
The 21st Century Cures Act (PUBL255.PS (congress.gov), established December 13, 2016 “is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to them.” The Cures Act section 505F included the potential use of Real World Evidence (RWE). According to the FDA, Real World Evidence is “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials and the “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.” download (fda.gov) RWE establishes its evidence by using Real Word Data from medical billing claims, electronic health records, clinical registries, and mobile devices. This strategy provides more information on the safety and efficacy of a device beyond the limitations of a clinical trial.
The Center for Devices and Radiological Health (CDRH) is a branch of the Food and Drug Administration that provides pre-market approval of medical devices and radiation emitting products. CDRH RWE is one way to provide quicker and more informed decision making in regulatory approval of devices. CDRH recently published its analysis of regulatory submissions which included RWE. Over 90 examples can be reviewed here: Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (fda.gov).
For example, one medical device for Spinal Posterior Ratcheting Rod System, used serious adverse events and reoperations as Real World Evidence in its submission for approval in addition to other data for use in patients with idiopathic scoliosis. (Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (fda.gov), p. 29). In addition, the Edwards Intuity Elite Valve Heart Valve Replacement system was approved for use and the submission for approval also included Real World Data by accounting for the surgical times for a cardiopulmonary bypass (Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions (fda.gov), p. 34.
The FDA also has provided guidance on RWE here Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (fda.gov). Per the guidance, RWE can be used but is not limited to:
expanded indications for use of a medical device
post market surveillance studies
post-approval device surveillance as condition of approval
supplementary data.
One initiative to incorporate RWE is The National Evaluation System for health Technology or NEST. NEST will gather data regarding medical devices to ensure their safety and effectiveness. Leveraging Real World Evidence in Regulatory Submissions of Medical Devices | FDA
Real World Evidence is a beneficial tool that will ultimately assist in providing quicker and more reliable medical device products to market. Using RWE pulls from industry application of devices and the data on their effects. If you are preparing a regulatory submission and need assistance with utilizing RWE or RWD, Clinical Pathways can provide training as it is important to know how to apply these methods.
Would you like more information about RWE? Check out our blog here FDA Framework for Use of Real-World Evidence — Clinical Pathways (clinicalpathwaysresearch.com) or contact us at info@clinicalpathwaysresearch.com for more information.
-The Clinical Pathways Team
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