medical devices Archives - In Compliance Magazine

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FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help medical device manufacturers identify human factors information to include in device marketing submissions.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Federal Bureau of Investigation (FBI) has issued a report detailing the potential cybersecurity risks associated with outdated and unpatched medical devices.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FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help ensure confidence in computers and automated data processing systems used in the production of medical devices.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

FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug Administration (FDA) may be adversely impacting the agency’s ability to thoroughly assess the security of medical devices against c... Read More...

FDA Updates Recognized Standards List

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 Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform for uploading and tracking the progress of premarket submissions for medical devices. According to a posting on the FDA’s... Read More...

MDSAP Extends Remote Auditing Option

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of remote auditing options under the scope of its Medical Device Single Audit Program (MDSAP). According to ... Read More...

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks applicable to EU reference laboratories (EURLs) specializing in the assessment of high-risk in vitro diagnostic medical dev... Read More...

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...

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