Medical Devices Archives - Page 3 of 11

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...

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...