VIA ELECTRONIC SUBMISSION
Robert M. Califf M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Re: Draft Guidance for Industry and Food and Drug Administration Staff—Use of Real World Evidence to Support Regulatory Decision-Making for Medical Devices (Docket No. FDA-2023-D-4395)
Dear Commissioner Califf:
The undersigned members of the Physician Clinical Registry Coalition (“Coalition”) appreciate the opportunity to provide comments to the Food and Drug Administration (“FDA”) on its draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The Coalition is a group of medical society-sponsored clinical data registries that collect, analyze, and report clinical outcomes data submitted by physicians, hospitals, and other providers to identify best practices and improve patient care. We are committed to advocating for policies that encourage and enable the development of clinical data registries and enhance their ability to improve quality of care through the analysis and reporting of clinical outcomes. Although the focus of our comments is the use of clinical data registries, we understand the FDA is not endorsing or encouraging one type of real-world data (“RWD”) over another. Additionally, we believe it is important to establish the study questions before determining the study design and the appropriate RWD sources suitable for the specific study questions.
Clinical data registries are a major source of RWD and critical partners in the generation of realworld evidence (“RWE”) for evaluating the safety and effectiveness of various medical procedures, drugs, and devices. The Coalition applauds the FDA’s continuing recognition that RWE can be used to inform agency decision-making across the regulatory lifecycle of medical devices. As the draft guidance acknowledges, RWD from registries can and has been used in a variety of contexts including:
Click here to read the full Neurosurgery Comment on Benefits of Registry Data for FDA Regulatory Purposes.
