New Rules Needed To Classify mHealth Products, Says Industry Coalition
This article was originally published in The Gray Sheet
Executive SummaryFDA needs new regulations to establish product classifications for mobile health accessories and software applications that do not fall within existing agency rules, a mobile health industry group urged in a draft proposal document issued Sept. 29.
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In response to an FDA proposal that would require unique device identifiers to improve post-market surveillance of medical technologies, the mHealth Regulatory Coalition argues that most mobile health apps should fall under exceptions to the rule.