ARTICLE SUMMARY:
Imperfect study data doesn’t mean a company needs to delay its FDA submission, but understanding whether it supports 510(k) clearance takes experience, judgement, and confidence. A sponsor should know the weaknesses of its application, give FDA options, and embrace an “incremental” regulatory strategy. In this edition of Consultants Corner, TSG Consulting’s Laurie Clarke discusses a recent client experience successfully turning a problematic data set into a 510(k) clearance.
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.
 Laurie Clarke (laurie.clarke@tsgconsulting.com) is VP and Principal for TSG Consulting’s medical device regulatory practice, where she helps companies develop and implement FDA strategies. She also serves as the in-house FDA regulatory advisor to the device product development team at TSG’s sister company, Sagentia Innovation. Prior to joining TSG in 2021, she was an Executive VP of Medical Devices and Combination Products at the consulting firm Greenleaf Health. And in her career as an attorney, she served as an FDA partner at the law firms Jones Day, King & Spalding, and Hogan & Hartson. |
The Question: Does Our Data Support 510(k) Clearance?
It’s rare for everything to go as planned in the course of collecting and compiling data for an FDA submission. But sometimes things can really go off the rails. A bit of bad advice, a study design that is difficult to implement, or a disappointing interaction with FDA. It’s not so hard for a company, particularly one with little to no experience dealing with the agency, to hit a wall and feel like its only option is to start from scratch or throw in the towel.
