FDA

FDA Issues Guidance on 510(k) Exemption of Certain Low-Risk Devices

By MedTech Intelligence Staff

21st Century Cures Act, signed into law on December 13, 2016, granted the FDA authority to exempt from 510(k) requirements Class II and Class I reserved devices the agency believes…

21st Century Cures Act, signed into law on December 13, 2016, granted the FDA authority to exempt from 510(k) requirements Class II and Class I reserved devices the agency believes…

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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FDA Releases Draft Guidance for Multiple Function Devices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

By MedTech Intelligence Staff

…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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21st Century Cures Act Passes Senate, Several Impacts to Device Industry

By MedTech Intelligence Staff

Last week the U.S. Senate passed the 21st Century Cures Act, a bill that supporters say will expedite the pathway way for medical technologies. Several provisions impact device manufacturers, including:…

Last week the U.S. Senate passed the 21st Century Cures Act, a bill that supporters say will expedite the pathway way for medical technologies. Several provisions impact device manufacturers, including:…

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Regenerative Medicine

The Steady Progress of Regenerative Medicine

By Maria Fontanazza

…medicine, from global reimbursement issues and coding policies for these products to ethical issues. ARM indicates that the 21st Century Cures Act could bode well for the field, as it…

…medicine, from global reimbursement issues and coding policies for these products to ethical issues. ARM indicates that the 21st Century Cures Act could bode well for the field, as it…

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