Unauthorized Blood Pressure Devices: FDA Enforcement Is Expanding and What Device Companies Need to Prepare For

info0940688
Dec 1, 2025
2 min read

Updated: Dec 17, 2025

Person in blue scrubs checks blood pressure with a monitor on a white table. The background is a plain dark blue. Calm mood.

The FDA’s recent safety communication on over-the-counter blood pressure monitors and wearable devices is one of the most significant enforcement signals the device industry has seen in years.

Smartwatches, rings, wristbands, and connected devices have flooded the consumer health tech market. Many companies have leaned into disease-related claims without securing the required 510(k) or other marketing authorization. That era is coming to an end.

What the FDA’s Safety Communication Means

In September and October, the FDA warned consumers and manufacturers that a growing number of over-the-counter products claiming to measure blood pressure have no FDA authorization, even though they make clinical or diagnostic claims.

This creates three major areas of concern.

1. Consumer harm. Inaccurate blood pressure readings can lead to misdiagnosis, incorrect medication adjustments, delayed treatment, and increased risk of cardiovascular events.

2. Device classification mistakes. Many companies assume that a consumer product is not a medical device. The moment a product claims to measure, diagnose, or monitor a condition, it falls under medical device regulation.

3. Marketing platforms under scrutiny. Online marketplaces and app stores have been hosting unauthorized devices, and the FDA has increased surveillance and enforcement.

Key Compliance Steps for Device Companies

1. Reevaluate your intended use in writing. Your intended use determines how the FDA classifies your product. If you claim to measure blood pressure, you need the appropriate premarket submission.

2. Conduct a thorough gap analysis of your labeling and digital marketing. Many companies comply with packaging but violate regulations through advertising, app descriptions, website copy, and influencer content.

3. Confirm the correct regulatory pathway. Most blood pressure monitors fall under product code DXN for noninvasive blood pressure measurement. These devices typically require a 510(k) submission.

4. Implement post-market controls even if you believe your product is not a device. Complaint files, adverse event tracking, malfunction logs, and corrective actions are required under device quality systems.

5. Strengthen quality systems before enforcement increases. The FDA is expanding inspections of small and emerging device companies, especially those selling directly to consumers.

Why This Matters for Wearable Tech Startups

The line between a wellness product and a medical device is extremely thin. Many startups cross it without fully understanding the regulatory implications. If your product provides a number that influences medical decision-making, the FDA will almost certainly treat it as a medical device.

Ignoring this reality does not reduce the risk. It simply increases the chance of enforcement.

The Strategic Imperative

Companies that classify, test, validate, and document their devices now will be positioned to compete with confidence. Companies that continue to market unauthorized devices are moving toward warning letters, platform removals, retailer restrictions, and increased liability exposure.

Strong regulatory planning is no longer optional. It is the only sustainable path for any company in the blood pressure, vital sign, or consumer health measurement space.