Jordanna Jayne

Realizing the Promise of Real-World Evidence in MedTech

By Jordanna Jayne, Ph.D.

Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase…

Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase…

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Joerg Schwarz, Infor
Soapbox

Why the Future of U.S. Patient Care Begins with Interoperability

By Joerg Schwarz, Ph.D.

…As we are transitioning to value-based care, the 21st Century Cures Act from 2016 makes it mandatory to share data, unless some specific exceptions can be invoked. This shift from…

…As we are transitioning to value-based care, the 21st Century Cures Act from 2016 makes it mandatory to share data, unless some specific exceptions can be invoked. This shift from…

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Tara Lysechko, Starfish Medical

Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?

…and when general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device. The 21st Century Cures Act (Cures Act) The Cures Act was…

…and when general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device. The 21st Century Cures Act (Cures Act) The Cures Act was…

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FDA

FDA Releases Draft Guidance for Multiple Function Devices

By MedTech Intelligence Staff

…for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that when assessing a product that has multiple functions,…

…for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that when assessing a product that has multiple functions,…

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Scott Gottlieb, FDA

FDA’s Innovation Initiative Aims to Prevent Regulatory Barriers

By MedTech Intelligence Staff

21st Century Cures Act Deliverables. Under the Act, CDRH has already taken several actions, including exempting more than 70 Class I devices from submitting a 510(k), exempting more than 1000…

21st Century Cures Act Deliverables. Under the Act, CDRH has already taken several actions, including exempting more than 70 Class I devices from submitting a 510(k), exempting more than 1000…

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Duodenoscope, ECRI

510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs

By MedTech Intelligence Staff

…entrap debris. “FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types…

…entrap debris. “FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types…

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Scott Gottlieb, FDA

Scott Gottlieb Confirmed as FDA Commissioner

By MedTech Intelligence Staff

…issues, including improving the FDA review process, reauthorization of MDUFMA and implementing the 21st Century Cures Act. “Dr. Gottlieb recognizes the crucial role of medical technology in solving some of…

…issues, including improving the FDA review process, reauthorization of MDUFMA and implementing the 21st Century Cures Act. “Dr. Gottlieb recognizes the crucial role of medical technology in solving some of…

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FDA

FDA Releases Proposed List of 510(k) Exempt Class II Devices

By MedTech Intelligence Staff

…– FDA The agency has published the notice and is requesting public comment, which ends on May 15, as part of the procedures established by the 21st Century Cures Act….

…– FDA The agency has published the notice and is requesting public comment, which ends on May 15, as part of the procedures established by the 21st Century Cures Act….

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Robert Califf, FDA

FDA Commissioner Califf Hasn’t Heard from Trump Yet

…foods and veterinary medicine, will step up to the plate. During the WP interview, Califf drew attention to the 21st Century Cures Act, which President Obama signed into law last…

…foods and veterinary medicine, will step up to the plate. During the WP interview, Califf drew attention to the 21st Century Cures Act, which President Obama signed into law last…

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