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Wellness Device Firms Should Follow Regulatory Prompts, Expert Says

This article was originally published in The Gray Sheet

Executive Summary

Many wearable consumer health products entering the market don't fall within the bounds of FDA regulation, but that does not mean companies selling the products should ignore recommendations coming out of the agency, according to Vernessa Pollard, a partner with McDermott, Will & Emery, who spent six years at FDA's Office of Chief Counsel. Maintaining validation according to FDA rules and guidelines makes "good business sense," she said in an interview.

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