FDA

FDA Official Dispels Medical Device Security Myths

Despite progress in improving medical device safety, many myths and misunderstandings about medical device security continue to persist, says Dr. Suzanne Schwartz of the FDA.”We have seen a fair amount of progress that has been very encouraging,” Schwartz says in an interview with Information Security Media Group. “With regard to manufacturers … we’ve seen great

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FDA piloting a path for digital innovation

Earlier this year the US Food and Drug Administration (FDA) heralded the forthcoming launch of its pre-certification pilot program for new digital health software which it hopes will help revolutionise the regulation of digital healthcare solutions in the US and allow innovations to safely reach the global market in a timely way, to the benefit

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FDA announces new market pathway for genetic health risk tests

FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an

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FDA advisers urge approval for first gene therapy for inherited disease

A Food and Drug Administration advisory committee unanimously endorsed an experimental gene therapy Thursday for patients with a rare kind of hereditary blindness, setting the stage for a historic approval.If the agency agrees with the recommendation, the one-time treatment would be the first gene therapy cleared in the United States for an inherited disorder.Made by

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