Dec 20, 2019
The AHA commented on the Food and Drug Administration’s draft guidance for industry and FDA staff on clinical decision support software as part of the agency’s efforts to implement Section 3060(a) of the 21st Century Cures Act.
Nov 25, 2019
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
Nov 18, 2019
The Food and Drug Administration Friday approved the first duodenoscope with a disposable elevator component, a part difficult to clean and reprocess.
Jun 7, 2019
The Centers for Disease Control and Prevention this week announced an anticipated shortage of Aplisol, one of two TB skin tests licensed by the Food and Drug Administration.
Mar 27, 2019
The Food and Drug Administration is working to prevent potential medical device shortages due to the closing of a Willowbrook, Ill., facility that sterilizes medical devices.
Mar 15, 2019
The AHA responds to the request for information on medical device interoperability from the Networking and Information Technology Research and Development’s Health Information Technology Research and Development Interagency Working Group.
Feb 4, 2019
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.
Jan 28, 2019
The Healthcare and Public Health Sector Coordinating Council (HSCC) today released a consensus-based guide to developing, deploying and supporting cyber-secure medical devices and health information technology across the product lifecycle and improving information sharing between manufacturers and…
Dec 11, 2018
Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates after reprocessing.
Nov 5, 2018
The Food and Drug Administration’s policies and procedures were insufficient for handling postmarket medical device cybersecurity events, and the agency has not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices.