By: Christopher A. Parrella, Esq., CPC, CHC, CPCO Parrella Health Law, Boston, Ma. The U.S. Food and Drug Administration (FDA) recently issued draft guidance clarifying the evaluation of real-world data (RWD) for regulatory decision-making regarding medical devices. This move reflects the FDA’s recognition of the increasing relevance of RWD in understanding patient health and healthcare delivery, as RWD is routinely collected from various sources such as electronic health records (EHRs), registries, and administrative claims data??. The FDA aims to determine if RWD is of sufficient quality to generate real-world evidence (RWE) that can support regulatory submissions for medical devices. This includes expanded recommendations for sponsors who consider using RWE to support their regulatory submissions??. RWD sources are diverse and primarily intended for purposes other than regulatory submissions, such as billing or tracking disease progression. The FDA acknowledges the multifaceted use of these data sources, which range from tracking overall outcomes and hospital operations to informing performance improvement initiatives and providing risk prediction for specific therapies. The suitability of an RWD source is determined based on several factors, such as its ability to sufficiently address the study question of interest. Importantly, the FDA does not endorse one type of RWD over another, instead encouraging sponsors to select RWD sources appropriate for their specific study questions??. This guidance represents a significant step in the FDA’s approach to incorporating modern data collection and analysis methods into its regulatory framework, acknowledging the evolving landscape of medical device evaluation and approval. If you have any questions or concerns regarding the draft guidance, please contact Parrella Health Law at info@parrellahealthlaw.com or call 857-328-0382. Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)