medical devices Archives - Page 3 of 21

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...

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan to harmonize its current good manufacturing practice requirements applicable to medical device quality systems with internati... Read More...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process. Th... Read More...

Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat of cyberattacks, a new report suggests that cyber vulnerabilities continue to be a major source of concern for connec... Read More...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the use of so-called 3D printing technology in the production of medical devices in hospitals and doctors’ offices. The paper, “... Read More...

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical device instructions in electronic form under the scope of the EU’s Medical Device Regulation (EU 2017/745, or the ... Read More...

FDA Updates List of Recognized Standards for Medical Devices

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...

EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical device database intended to serve as a repository for detailed information on medical devices approved under the EU’s Medica... Read More...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently released a document outlining “guiding principles” essential to the development of medical devices using artificial i... Read More...

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