medical devices Archives - In Compliance Magazine

FDA Releases New Video on Cybersecurity in Healthcare Facilities

As part of its effort to protect healthcare workers and patients from equipment malfunction attributable to cybersecurity breaches, the U.S. Food and Drug Administration (FDA) has released a new video to help h... Read More...

FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new voluntary pilot program aimed at improving technologies and practices used in the sterilization of medical devices. According t... Read More...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its regulations under the EU’s Medical Device Regulation (2017/745, or MDR) and the In Vitro Diagnostic Regulation (2017/746... Read More...

FDA Posts Updated FAQs on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released an updated list of frequently asked questions (FAQs) on the agency’s requirements regarding cybersecurity provisions applicable to medical devices. Pu... Read More...

FDA Releases Third-Party Review Performance Report

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. ... Read More...

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for existing medical devices under its Medical Device Regulation (EU 2017/745, also known as the MDR) and the In Vitro Diag... Read More...

FDA to Host Webinar on In Vitro Diagnostic Devices EMC

The U.S. Food and Drug Administration (FDA) will host a webinar in early February on its requirements regarding the electromagnetic compatibility (EMC) of in vitro diagnostic (IVD) medical devices. According... Read More...

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help medical device manufacturers identify human factors information to include in device marketing submissions. Issued in ... Read More...

FBI Recommends Actions to Protect Medical Devices from Cyberattacks

The U.S. Federal Bureau of Investigation (FBI) has issued a report detailing the potential cybersecurity risks associated with outdated and unpatched medical devices. The report, titled “Unpatched and Outdat... Read More...

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help ensure confidence in computers and automated data processing systems used in the production of medical devices. Publis... Read More...

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