The Food and Drug Administration recently released draft guidance outlining the regulatory agency’s recommendations on design considerations for manufacturers seeking to develop interoperable medical devices. However, critics argue that the guidelines are not enough to ensure device interoperability.
The FDA guidance is meant to provide the industry with a “reasonable assurance of safety and effectiveness of their interoperable medical devices,” according to Bakul Patel, associate director of digital health in the FDA’s Center for Devices and Radiological Health.
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