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Troutman Pepper

Software as a Medical Device: FDA Releases Draft Guidance

Troutman Pepper on

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

Ballard Spahr LLP

FDA Issues Guidance on Mobile Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

Kelley Drye & Warren LLP

FDA Extends Risk-Based Medical App Approach to Medical Device Data Systems in New Guidance

Kelley Drye & Warren LLP on

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that...more

Sheppard Mullin Richter & Hampton LLP

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Sheppard Mullin Richter & Hampton LLP on

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

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