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FDA Provides Wellness Device Testing Guidelines. What's Your Next Move?

[fa icon="calendar"] Sep 7, 2016 3:25:07 PM / by Pat Flanders

Pat Flanders


Last month, the US Food and Drug Administration (FDA) released a document that provides guidelines and compliance information for companies that manufacture wellness devices. As opposed to devices that are invasive or provide extensive screening or testing capabilities, wellness devices are in a category the FDA considers "low risk", and outlines the classification within the document.

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We already see a lot of devices in this market; fitness trackers, sleeping aids, exercise guides, and a host of other items that are intended to give the consumer the ability to manage and guide his own general state of wellness. Interestingly, the FDA has chosen to exempt from oversight those devices that are purely for tracking of general wellness and are used to promote a healthy lifestyle.

As technology provides new and better ways for individuals to collect and analyze their own health and medical data, there will be more products coming to market. These will come in the form of new categories, and as a result, we will continue to see more definition around what does and does not require testing. Device developers will need to pay close attention to understand how to categorize their products. They will then need to act accordingly and be prepared to provide full testing and validation.

The smart move is to think "quality-first", as all health-related devices require a variety of different types of testing. Product developers will want to develop with quality safeguards in place, but also by being prepared for whatever testing they may need to do.

We invite you to learn more about how to implement quality and testing into your life sciences:

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Topics: Quality & Compliance, Medical Devices, FDA

Pat Flanders

Written by Pat Flanders