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AHA Comments on FDA Guidance on Clinical Decision Support Software
The AHA commented on the Food and Drug Administration’s draft guidance for industry and FDA staff on clinical decision support software as part of the agency’s efforts to implement Section 3060(a) of the 21st Century Cures Act.
FDA takes steps to expedite innovation in ethylene oxide sterilization
The Food and Drug Administration today announced a voluntary pilot program to expedite approvals of certain changes to ethylene oxide sterilization processes and facilities.
FDA approves duodenoscope with disposable part
The Food and Drug Administration Friday approved the first duodenoscope with a disposable elevator component, a part difficult to clean and reprocess.
CDC anticipates shortage of TB screening test
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.
FDA: Closure of medical device sterilization facility could prompt shortages
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.
RFI Response: Action on Interoperability of Medical Devices, Data and Platforms to Enhance Patient Care
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.
FDA issues draft guidance on cybersecurity for medical device industry
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk.
FDA announces actions to strengthen medical device cybersecurity
The Food and Drug Administration today released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices.
FDA releases early results from duodenoscope reprocessing studies
Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates after reprocessing.
FDA: Don’t use certain test strips to monitor blood thinner dosing
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.