Ensure user safety and support marketing claims for consumer products and consumer devices with certification, clinical validation, and usability testing.

In the United States, when a company does not want to sell a health monitoring device as a “medical device” (i.e., a device that is used to make medical decisions or diagnoses regarding healthcare), the product can be brought to market as a consumer product. These consumer products are also known as consumer devices, over-the-counter devices, and wellness products.

What are consumer devices?

Consumer devices, also referred to as wellness products, are designed to merely collect and display general health information for personal use and are not associated or intended to be used in high-risk medical diagnostic situations. According to FDA regulatory guidance, these devices can't be invasive or implanted. If technology would pose a risk to patients if specific regulatory controls are not in place, it can't be used in these devices.

Wellness products fall into two categories – products that look to improve overall health without referencing specific diseases and conditions, and those that do. The FDA states that wellness product claims for specific diseases or conditions “should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition."

Many companies choose to validate and test these devices to ensure user safety and support any marketing claims made. The marketing claims are very important to ensure the product is being used and marketed correctly. If a product oversteps its marketing claims and is used in a diagnostic purpose, the FDA can step in and regulate. So, let’s talk about your device and how our consumer product testing services can make a difference.

How consumer device testing is conducted

Existing industry standards can be used by manufacturers of consumer products to demonstrate effectiveness outside of regulatory clearance, depending on the type of product and what it is intended to measure.

For example, manufacturers of blood pressure monitors can achieve VDL certification on the US Blood Pressure Validated Device Listing, a third-party certification site that uses standards such as ISO 81060-2 to evaluate the product.

For manufacturers seeking VDL certification, Element offers testing per ISO 81060-2, as well as industry-standard testing for heart/pulse rate, temperature, SpO2, and respiratory rate monitors. Additionally, our laboratory offers human factors, or usability testing, providing valuable feedback for any device. Want to know more? Start the conversation today.

Accuracy testing for non-medical applications

Element provides accuracy testing for various non-medical applications where these sensors may be incorporated, including:

  • Sports
  • Aviation
  • Virtual reality
  • Touchless tablets
  • Industrial applications

Request a quote for accuracy testing of your device today.

The Element advantage

Demonstrate effectiveness of consumer devices outside of regulatory clearance when you partner with Element. Bring optimized devices to market with our wraparound services, including human factors and usability testing. Interested in knowing more about Element’s consumer product and consumer device testing services? Contact our experts today.

FDA Guidance Document - General Wellness: Policy for Low Risk Devices

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