Wellness Device Firms Should Follow Regulatory Prompts, Expert Says


Vernessa Pollard said “it just makes good business sense” for companies that sell wearable consumer health products to validate them, even if they are not regulated by the FDA. “If there is a possibility that the information [from the consumer product] could be incorrect or inaccurate, and those inaccuracies may impact [patient] health in some way, then from a business standpoint it’s sensible to validate the device whether it’s regulated as a medical device or not,” Ms. Pollard explained.