medical devices Archives - In Compliance Magazine

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility (EMC) in connection with medical devices, including in vitro diagnostic (IVD) devices. Posted to the FD... Read More...

EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards for quality management systems and risk management practices applicable to medical devices under the EU’s In Vitro Device R... Read More...

FDA Updates List of Recognized Standards

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain its criteria for assessing whether a medical device premarket notification (510(k)) submission meets the agency’s minimum re... Read More...

FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than 650 medical devices designations under its Breakthrough Devices Program. The Breakthrough Devices Program, which replaced the... Read More...

Senate Introduces Medical Device Security Act

The U.S. Senate has introduced a bipartisan measure that would help to ensure the security and integrity of medical devices by implementing mandatory premarket cybersecurity requirements. Introduced in mid-M... Read More...

FDA Clarifies Cybersecurity Recommendations for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that contains recommendations for medical device manufacturers on ensuring the security of their devices from cyberattacks. Pu... Read More...

FDA Warns of Medical Device Cyber Vulnerabilities

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device manufacturers and users regarding a cybersecurity vulnerability identified in connection with a widely used web-based software t... Read More...

FDA Releases Final Guidance on Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help medical device manufacturers and others facilitate the execution of voluntary product recalls. The guidance, “Initiation of Vol... Read More...

Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the European Commission to extend the transition period for the EU’s Medical Device Regulation (2017/745) to avoid what they call a ... Read More...

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