In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC).

This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.

Key Timestamps

02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?
06:45 – Implications of removing the healthcare provider from the equation
12:00 – Risk management: Expanding risk profiles when lay users are involved
18:15 – When a 510(k) becomes a De Novo or PMA
22:50 – Usability testing and the risk of user error in OTC devices
31:20 – Clinical investigations and good clinical practices (GCPs)
36:00 – Real-world evidence vs. real-world data—what’s usable?
41:30 – Using Pre-Subs effectively and what “quality data” really means
47:10 – Labeling, cleaning, and UDI for OTC products
53:40 – OTC software and digital health—when is it a regulated device?
01:00:00 – Summary: Aligning regulatory logic with common sense and business strategy

Quotes

“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”

– Mike Drues

This quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.

“If the clinical trial won’t tell you anything you don’t already know from good real-world evidence, why spend the time and money?”

– Mike Drues

A powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.

Top Takeaways

Label Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.
Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.
Real-World Evidence Can Help—If It’s Clean: Real-world data isn’t always usable. FDA will expect reproducibility, traceability, and strong justifications.
Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.
Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.

References & Resources

Etienne Nichols on LinkedIn
FDA Guidance on Real-World Evidence for Regulatory Decision-Making
Greenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)
FDA Guidance: Clinical Decision Support Software

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