FDA Issues Draft Guidance on Interoperable Medical Devices

Überblick


Michael Ryan and Daniel Gottlieb said that “industry needs more substantive and specific guidance” than was given in FDA draft rules on how the agency evaluates medical devices that connect to and interact with other devices or systems. “At a high-level, the principles articulated in the draft guidance are reasonable and consistent with information security best practices,” the two lawyers noted, adding that “the burden the draft guidance imposes on the development of any individual product is unclear because the FDA retains considerable discretion when evaluating regulated devices.”