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Home » Keywords: » FDA

Items Tagged with 'FDA'

ARTICLES

AI-ML 5-25

Agencies Issue Guiding Principles For AI/ML-Enabled Medical Devices

May 25, 2022

WASHINGTON—The U.S. Food & Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have jointly identified 10 guiding principles that can help manufacturers build safe, effective and high-quality medical devices that enable artificial intelligence and machine learning.


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FDA 11-24

FDA Publishes Good Machine Learning Practices Guide For Medical Device Manufacturers

November 23, 2021

WASHINGTON—In conjunction with Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, the U.S. Food and Drug Administration has published 10 guiding principles for Good Machine Learning Practice in the development of medical devices.


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FDA 11-25

FDA Approves 3D-Printed Instruments for Total Ankle Replacement

November 20, 2020

ROCK HILL, SC–The FDA has provided 510(k) clearance for a patient-specific, 3D-printed instrument set used during ankle replacement surgery with Exactech’s Vantage Total Ankle System.


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Breaking and Industry News

American and Korean Medical Device Manufacturers Collaborate on Ventilator Production

April 13, 2020

IRVINE, CA — BIOLASE Inc. announced that it expects to partner with MEKICS Co. Ltd, an intensive care unit (ICU) equipment manufacturer, to supply ICU-grade portable ventilator through BIOLASE's FDA-registered manufacturing facility in California.


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FDA to Modernize 510(k) Clearance Pathway

FDA to Modernize 510(k) Clearance Pathway

Sprovieri200
John Sprovieri
April 2, 2019
The Food and Drug Administration is changing the most common way it approves new low- to moderate-risk medical devices for use in the United States.
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medical-device-assembly.jpg

Government Shutdown Delays Medical Device Approvals

October 11, 2013

WASHINGTON—The federal government shutdown is delaying reviews and approvals of medical devices.


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Breaking and Industry News

FDA Orders Dental Implant Manufacturer to Cease Production

February 15, 2012

NEWARK, NJ—The FDA has ordered a manufacturer of dental implants to stop production after finding numerous quality control violations at the company’s assembly plant here.


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