ARTICLE SUMMARY:
FDA has increasingly made it clear that real-world evidence is a welcome component of premarket submissions. In this edition of Consultants Corner, Justin Eggleton, from MCRA, addresses common sources of skepticism and explains how industry can embrace the RWE opportunities.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
 Justin Eggleton (jeggleton@mcra.com) is VP, Head of Musculoskeletal Regulatory Affairs, for the global CRO and advisory firm MCRA, where he leverages expertise in biomechanics, biomaterials, and regulatory science to manage regulatory projects for an array of spine device categories. He previously worked at FDA, where he was a lead reviewer in the FDA Orthopedic Devices Branch, and he also contributed to guidance and technical standards in orthopedics. |
Question: Is RWE Realistic for Most FDA Premarket Submissions?
Ten years ago, many experts would have said “no” to the idea that FDA would routinely accept data collected by healthcare providers in the regular course of patient care as primary evidence in a 510(k), PMA, or other submission. But it was at about that time when Justin Eggleton, who assists spine device companies on FDA projects, says he started to notice a shift.
Somewhere around 2012, he and a client company saw an opportunity to include some real-world data in an upcoming submission. At the time, it seemed like a risky proposition. Real-world evidence (RWE) “wasn’t really considered an option” for FDA submissions, he explains. “We thought we were pushing the boundaries.”
It turned out the agency’s staff was interested. Reviewers posed a lot of on-point questions about the data and, ultimately, Eggleton says, they cleared the 510(k). They were more prepared than he expected, and it made him think FDA was likely having discussions behind closed doors about the topic.
FDA had already been promoting the so-called Total Product Lifecycle (TPLC) as a mechanism to describe the feedback loop responsible for managing device evolution, Eggleton observes. “My guess is that FDA took a hard look at this and, much to their credit, recognized TPLC would always be somewhat muted without stronger data input from real-world use.”
