New FDA Guidance Could Support Digital Transformation in Medical Devices

The digital transformation sweeping across health care is moving quickly. Like most things regarding technology, regulation is slow to keep up, but the Food and Drug Administration’s perspective on regulating new wearable technology and mobile apps is getting a little clearer. The agency recently issued draft guidance stating that it wouldn’t regulate “low-risk” devices that are intended for general wellness. That classification includes smart watches, fitness trackers, which offer health information to people.

Under the draft guidance, a device that makes a claim to improve the general health of the user won’t be regulated, explains Regulatory Focus. But if a device maker claims its product treats or diagnoses a disease or medical condition, that product would fall under FDA regulation as a medical device. Where a device falls along this regulatory divide will help determine what kind of regulation it will likely receive from the FDA. The distinction is one of risk that is similar to the risk classifications by which the FDA gauges medical devices. A wearable device functions outside of the body, and therefore, poses less of a risk. But medical devices that enter the body, either by injection, ingestion, or implantation, are more invasive. Those devices will necessarily require closer regulatory scrutiny. Device makers whose products work outside of the body should not make the mistake of thinking that they will win the blessing of the FDA, cautions Popular Science.

“Keep in mind, though, that isn’t the same as saying that the FDA approves those devices—it’s simply not regulating them,” Popular Science says.

Wearables are already starting to show their potential as products that can provide continuous monitoring of patients, which has applications both in clinical trials and in a hospital setting. But now that the distinctions between what the FDA will regulate and what it will not regulate are becoming clearer, expect more wearable technologies with offering various capabilities vie for a share of the market.

Learn more about the ongoing digital transformation within medical devices

Join experts from the top medical device organizations on April 27-29, 2015 in San Francisco at Digital Marketing for Medical Devices West to leverage digital to expand your reach, foster brand loyalty and add value for your customers. To learn more about this event, download the brochure or visit the website. Click here to register and be sure to mention Priority Code BLOG.

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