ARTICLE SUMMARY:
Cybersecurity and human factors assessments are shifting for many devices from “nice to haves” to baseline FDA review requirements. Rather than resist this evolution, companies should welcome it as a means to ensure more devices are ready for real clinical environments once they get cleared—MCRA’s Nikki Batista and Lauren White make the case in this edition of Consultants Corner.
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.
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Nikki Batista (nbatista@mcra.com) is VP of Digital Health Regulatory Affairs for the global CRO and advisory firm MCRA, where she has worked since 2019. Previously, she was a lead cardiovascular device reviewer and assistant director of the External Heart Rhythm and Rate Devices Team at FDA, where she also participated in the Digital Health Precertification Program. Lauren White (lwhite@mcra.com) is director of IT and Security at MCRA. Prior to joining MCRA in 2021, she was a security engineer and IT business manager at the health system MedStar Health. |
The Question: Does FDA Really Need This From Me?
Some device makers may be starting to notice new types of questions and expectations from FDA on their premarket submissions and wondering what gives.
Why is this request about user interface relevant for my device?
Isn’t this security issue something I can address with customers when it comes time to deploy the product?
