Summary
FDA's regulatory control on software products
The FDA continues to regulate medical prcatice software and hardware without Congressional sanction. The FDA's authority is derived from the Food, Drug and Cosmetic Act which provides a broad definition of medical devices.See the full content of this document
Extract
Software pirates.
Congress never gave the FDA power to control medical practice. But the agency seized it anyway - by regulating software and computers.
On July 1, 1997, the Food and Drug Administration arrested a laser. The laser belonged to Trevor Woodhams, an eye surgeon in Atlanta who has been practicing for 15 years and runs the Woodhams Eye Clinic. He uses surgical eye lasers, or excimer lasers, to treat nearsightedness and astigmatism. Woodhams built his laser because the existing, FDA-approved models didn't allow surgeons to perform techniques that are state of the art elsewhere in the world. In contemplating how the FDA might respond, he believed he had two things going for him: First, doctors who build one-of-a-kind devices can be exempt from standard FDA regulation if they meet certain criteria, and Woodhams's lawyer had assured him that the "custom device" exemption applied to him. Second, the FDA has repeatedly said it does not regulate medical practice - device manufacturers, yes; doctors, no. Which is why Woodhams was a bit surprised in mid- 1996, soon after he built his laser, when the FDA told him the custom device exemption didn't apply to him and that, as a regulated device manufacturer, he was violating the law by making and using an unapproved device. To get FDA approval for a device, you need to do studies, and to do studies, you need an investigational device exemption (IDE). Woodhams didn't agree that he was subject to FDA regulation in the first place, but the FDA had more money and more lawyers. "As a private prac...See the full content of this document
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