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Week #10

Wearables – Avoiding the FDA

It’s not a Medical Device!

Not only are electronics getting smarter, they are also getting smaller and lighter. Aswireless communication has improved, and product sizes have shrank, a new category
of “wearable” electronics has emerged. This new product category is expected to be one
of the fastest growing segments within the field of consumer electronics. Initially
dominated by fitness trackers, many new forms of wearables are now being developed
including smart glasses, intelligent fabrics/clothing, and even smart patches worn directly
on the skin.

Within the wearables category are the fitness trackers and other devices that monitor a
user’s fitness, well-being, and health. Many new products have been introduced to the
market that provide medical information to the user, but are not intended to be medical
devices. The fear of course for manufacturers of these devices is the oversight of the US-

The good news is that the FDA doesn’t really want to review these types of products. To
help define which types of wearable products are considered “Medical Devices” subject
to the rules and regulations of the FDA, official FDA guidance documents have been
published. The FDA has recently published:

By following these guidance documents, manufacturers of wearable electronics can
avoid the rules and oversight of the FDA. In questionable cases, it is even possible to
present your position to the FDA and get an official ruling – this can be done as early as
the product concept stage.

CertifiGroup provides Testing Services for Wearables
CertifiGroup can obtain an official FDA decision on your Wearables

CertifiGroup can also Certify your
Medical & Non-Medical Products

Experts in UL, CSA, CE, & International Regulatory Compliance

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