Michael D. Shalhoub, Co-Chair of Goldberg Segalla’s Life Sciences Practice Group, was interviewed by the Wall Street Journal on the guidance recently issued by the Food and Drug Administration on mobile medical apps. The guidance laid out the agency’s thinking regarding when it will consider an app a medical device requiring FDA approval and oversight and when apps won’t meet that regulatory standard.
Although the rules are only “guidance” to help the medical devices industry understand them before it starts exercising enforcement discretion, Mike told the Journal, device manufacturers should approach the rules as if they have the force of law. “They are a lot closer to mandatory,” he said.
Mike noted in the interview that for those devices deemed to be under FDA review, it pays for manufacturers to make sure they get the agency’s approval in case there should be a product defect case that makes its way to trial. Added to recent FDA guidance regarding wireless security and rules on unique identifiers for medical devices, “it looks like the agency really is paying attention to how technology is affecting innovation and treatment, and as stuff develops it is going to be paying attention to it,” he said.