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AHA Comments to FDA Re: Blood Glucose Monitoring Test Systems
AHA's comment on the Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use.
FDA issues draft guidance on cybersecurity for medical device industry
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA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: 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.
FDA issues draft guidance on point-of-care blood glucose monitors
The Food and Drug Administration today issued draft guidance describing the premarket studies that manufacturers should conduct for blood glucose monitoring systems intended for use in professional health care settings.
FDA alerts providers to medication pump danger
The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal implanted pumps when the medications are not approved for use with those devices, which deliver medicine into spinal fluid.