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New FDA Guidance Could Support Digital Transformation in Medical Devices

New FDA Guidance Could Support Digital Transformation in Medical Devices

The digital transformation sweeping across health care is moving quickly. Like most things regarding technology, regulation is slow to keep up, but the Food and Drug Administration’s perspective on regulating new wearable technology and mobile apps is getting a little clearer. The agency recently issued draft guidance stating that it wouldn’t regulate “low-risk” devices that are intended […]