FDA’S Weight-Loss Device Roadmap: What You Need to Know

If you’re in the weight loss sector, we have some exciting news to share from the Federal Drug Administration (FDA) that will shift the game when it comes to weight loss products. On September 15, 2023, they dropped not one, but two draft guidance documents related to medical devices with indications linked to weight loss. Let’s unpack them.

Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations (fda.gov)

These guidelines cover things like device descriptions, labeling, and safety regarding things like magnetic resonance imaging, electromagnetic compatibility, and even getting into the nitty-gritty with sterility/pyrogenicity, wireless tech, and performance concerns. Think things like corrosion resistance, durability, and how these devices play nice (or not) with others.

Medical Devices with Indications Associated with Weight Loss – Clinical Study and Benefit-Risk Considerations – Draft Guidance for Industry and Food and Drug Administration Staff (fda.gov)

Here, they dive into clinical studies and weigh benefit-risk considerations. They discuss patient demographics, safety endpoints and data, adverse events, clinical outcomes, and statistics.

Brand Name Examples

So, what does this mean for your brand naming projects? Let’s explore this topic with two unique strategies in the weight loss space that “did it right.”

• SmartByte® device from Scientific Intake is a custom-made device intended to be worn at mealtimes to slow/reduce food intake by reducing the capacity of the oral cavity (mouth in simpler terms). The word part “Smart” is unique because it may be a clever acrostic that refers to the device description (Sensor Monitored Alimentary Restriction Therapy (SMART) Device. Or, it could refer to the device helping patients take “smart bites” during use.
• Plenity®, from Gelesis, is a super-absorbent hydrogel to aid in weight management by occupying space in the stomach during mealtimes to reduce food intake. The brand name appears to evoke the word “plenty” and can be associated with feeling full, referred to as “satiety.”

These brands provide a clear and compelling message to patients and healthcare professionals by working with the guidance documents.

Key Takeaway

We’ll leave you with one more takeaway. These devices aren’t magic wands for shedding pounds. Any prescription medicine or device aimed at helping you lose weight should come with some education and counseling. We’re talking about learning how to lead a healthy lifestyle, improving your nutrition game, and getting active. It’s all about the long-term game plan!

And if you’re itching to share your thoughts on these documents, the FDA’s comment period on the draft guidance documents ends November 14, 2023.

That’s a wrap for the latest scoop on the FDA’s weight-loss gadget guidelines. Stay healthy, stay informed, and remember, we’re always here to help you make “smart” choices when it comes to branding your healthcare assets!