Tag Archives: FDA

Developing a mobile health app? FDA suggesting which laws you need to follow

FDA innovation planThe broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.

Providers and other stakeholders are using digital health in their efforts to:
– Reduce inefficiencies,
– Improve access,
– Reduce costs,
– Increase quality, and,
– Make medicine more personalized for patients.
– Patients and consumers can use digital health to better manage and track their health and wellness related activities.

The use of technologies such as smart phones, social networks and internet applications is not only changing the way we communicate, but is also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together these advancements are leading to a convergence of people, information, technology and connectivity to improve health care and health outcomes.

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FDA DIgital Health
FDA – Mobile Health Apps Interactive Tool
Hogan Lovells – navigating the US FDA regulatory clearance for digital medical devices

3D printing of medical products – FDA provides guidance to manufacturers

3D printing in healthcareDecember 4, 2017 – The U.S. Food and Drug Administration (FDA) on December 4 released a new set of recommendations for creating medical products using 3D printers. The guidance details the agency’s stance on device design, testing, and quality system requirements.

For a relatively new technology, 3D printing has a wide range of clinical applications, such as building functionally accurate replicas of complex anatomical structures and facilitating surgery simulations to restore hearing loss, remove stroke clots, and repair hip disorders. The rapid evolution of this technique has led the FDA to release an early policy framework to help manufacturers bring 3D-printed models to the market more efficiently.

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