Turning FDA Warnings Into Opportunities: Advancing Blood Pressure Devices Through Validation

On September 16, 2025, the FDA issued a safety communication warning consumers and healthcare providers about the risks of using unauthorized devices that claim to blood pressure, including certain smartwatch and smart ring features. The agency emphasized that devices without FDA marketing authorization have not been evaluated for safety or effectiveness—leaving users vulnerable to inaccurate readings and potentially harmful health decisions. 

While this warning highlights the risks of unauthorized devices, it also underscores a powerful opportunity for innovators: advancing device development through proper FDA validation studies. 

Why FDA Authorization Matters 

Blood pressure monitoring is fundamental to managing hypertension, yet it requires highly accurate and validated technology. Inaccurate readings can result in missed diagnoses, unnecessary treatments, or serious complications such as stroke or heart attack. The FDA’s action reinforces that only authorized devices, supported by regulatory-grade evidence, can be trusted in clinical and consumer use. 

How Innovators Can Respond Positively 

Rather than viewing the FDA’s communication as a setback, developers should see it as a roadmap: 

• Commit to validation under standards such as ISO 81060-2 (cuff-based) and ISO 81060-7 (cuffless). 

• Engage with FDA early through Q-Submissions to clarify requirements and align on endpoints. 

• Invest in inclusive validation to ensure accuracy across diverse populations, including variations in age, sex, arm circumference, and skin tone (using the Monk scale). 

  
  

By embracing these steps, innovators strengthen their devices, build trust with clinicians, and accelerate the path to FDA authorization. 

PRL’s Role in Accelerating Safe Innovation 

At Parameters Research Laboratory, we partner with developers to transform promising prototypes into regulator-ready devices. As a specialized blood pressure validation testing lab, we provide: 

• Clinical trial protocol development aligned with FDA expectations. 

• Controlled and compliant studies under ISO 81060-2, ISO 81060-7, ISO 14155, and GCP. 

• Regulatory strategy support, including FDA 510(k) submissions and CE mark pathways. 

• CRO risk mitigation and rescue studies to keep development on track. 

  
  

Our goal is not only to meet FDA requirements but to give innovators confidence that their devices can withstand regulatory scrutiny and earn trust in the marketplace. 

Moving Forward with Confidence 

The FDA’s safety communication is a reminder that unauthorized devices pose risks, but it also affirms the value of rigorous validation. Companies willing to invest in regulatory-grade studies are well-positioned to deliver safe, effective, and innovative blood pressure technologies that improve health outcomes worldwide. 

At PRL, we stand ready to support that journey—helping innovators turn compliance into competitive advantage. 

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