In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs).

This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.

• [03:05] – What defines an OTC vs. prescription medical device?
• [06:45] – Market size of OTC devices and major product categories
• 10:00 – Label expansion: moving from Rx to OTC status
• 13:22 – The role of intended use environment in OTC classifications
• 20:40 – Examples of devices in each FDA class that are OTC
• 26:30 – Prescription devices used in home settings vs. true OTC
• 31:15 – Characteristics that qualify devices for OTC status
• 37:55 – Self-diagnosis, self-selection, and patient usability challenges
• 43:00 – “Reasonably foreseeable misuse” and how to interpret guidance
• 49:05 – Do you design for the lowest common denominator?
• 56:10 – Representing diverse user populations in usability testing
• 1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies
• 1:08:15 – FDA’s perspective on device safety: OTC vs. Rx

“The best regulatory professionals don’t just know the rules—they know the exceptions.”

Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.

“Just because a device is used at home doesn’t mean it’s over the counter.”

This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.

1. OTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it’s more about intended user, use environment, and risk mitigation than class alone.
2. Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn’t just about removing a doctor’s role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.
3. Understand the "Intended Use Environment" – FDA doesn’t just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.
4. Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.
5. Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.

• Etienne Nichols on LinkedIn
• Greenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)
• FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...