FDA

FDA’s new draft guidance could hinder applications for digital combination products

Released yesterday, the document outlines FDA’s preference toward single applications for combination products. The FDA released new draft guidance yesterday regarding premarket review for combination products those with a mix of components that span across the agencys drug, biologic and device product categories.The proposed premarket guidance, which may still be adjusted based on public feedback,

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Healthcare And Medicine Needs A Global FDA

Globalization reached healthcare big time: a French patient can easily ask a Belgian company to sequence the DNA of his tumor tissue, then convince a Swiss pharma company to sign them up for a relevant clinical trial on a Spanish island. Not only that but also the recent controversies around gene editing in babies in

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FDA launches new tool aimed at safe deployment of AI in healthcare

The Food and Drug Administration is sticking its toe in the water of artificial intelligence, providing its first guidance on the emerging development of applications for the technology in healthcare.The FDA released model 1.0 of its software precertification pilot Monday to provide an initial tool to test these programs. The agency noted that with AI

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Roche launches FDA-approved diagnostic test for personalised cancer care in Singapore

Roche announced last week the launch of FoundationOne CDx, Foundation Medicines comprehensive companion diagnostic test for personalised cancer care in Singapore. According to the official media release, FoundationOne CDx supports clinicians in their decision-making by providing a clear, in-depth report that describes the unique genomic profile of a patients tumour as well as associated, approved

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FDA looks to restrict older predicate devices, introduce new regulatory pathway

To encourage healthcare technology innovation and update the 510(k) pathway, the regulatory agency said that it will soon release measures aimed to sunset predicate devices that are over a decade old. In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the FDAs Center for Devices and Radiological

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Proposed framework lessens FDA’s regulatory requirements for prescription drug companion apps

The FDA is seeking public comments for a proposed framework that would allow the majority of apps and software released by pharmas that accompany a drug treatment to avoid lengthy premarket review submissions.According to a notice released last week, such software would be viewed as promotional labeling, and therefore only require submission to the FDAs

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FDA’s Reworked Premarket Medical Device Guidance

The Food and Drug Administration’s recently issued draft document updating its premarket medical device cybersecurity guidance originally issued in 2014 contains several important provisions, says regulatory attorney Yarmela Pavlovic.”The 2014 guidance that FDA issued about premarket cybersecurity considerations was fairly sparse; it wasn’t particularly detailed,” Pavlovic notes in an interview with Information Security Media Group.

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FDA Calls for ‘Cybersecurity Bill of Materials’ for Devices

In addition to releasing the proposed guidance this week, the FDA announced a formalized agreement with the Department of Homeland Security to implement a new framework for greater collaboration between the two agencies for addressing cybersecurity in medical devices.”From my vantage point, it looks like everyone in the medical device security community is happy to

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FDA proposes updated cybersecurity recommendations to help ensure device manufacturers are adequately addressing evolving cybersecurity threats

Cybersecurity threats and vulnerabilities in todays modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations, said FDA Commissioner Scott Gottlieb, M.D. The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this

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