medical devices Archives - In Compliance Magazine

FDA Seeks Budget Increase, Especially for Medical Device Review

The U.S. Food and Drug Administration (FDA) is seeking an increase of over $550 million in its total proposed budget for fiscal year (FY) 2022, reflecting in part a significant increase in its budget for oversi... Read More...

FDA Issues Guidance on Medical Device Safety in MRI Facilities

The U.S. Food and Drug Administration (FDA) has issued its final guidance on assessing the safety of medical devices used in facilities using magnetic resonance imaging (MRI) technologies. Published in late ... Read More...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the EU are now fully applicable to all devices. As of May 26, 2021, all new and existing medical devices must now conform ... Read More...

FDA Releases 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. ... Read More...

FDA Warns of Potential Effects of Magnets in Cell Phones and Smartwatches

The U.S. Food and Drug Administration (FDA) is advising consumers with embedded pacemakers and other implanted medical devices to take precautions when using consumer electronics with integrated magnets. In ... Read More...

FDA Reverses HHS Action to Exempt Certain Medical Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has withdrawn a January proposal by the U.S. Department of Health and Human Services (HHS) to permanently exempt 91 separate medical device types from the FDA’s 510(k... Read More...

FDA Authorizes 50+ Testing Labs for Conformity Testing Pilot

The U.S. Food and Drug Administration (FDA) has now accredited more than 50 testing laboratories to participate in its voluntary Accreditation Scheme for Conformity Assessment (ASCA) pilot accreditation program... Read More...

FDA Releases Catalog of Regulatory Science Tools for Medical Devices

To facilitate the expanded use of innovative science techniques in the development of new medical device technologies, the U.S. Food and Drug Administration (FDA) has published a collection of regulatory scienc... Read More...

FDA Posts Biocompatibility Resource Center

The U.S. Food and Drug Administration (FDA) has collected a variety of resources to assist medical device manufacturers in their evaluation of their products for biocompatibility considerations. Biocompatibi... Read More...

UK Passes Post-Brexit Medical Device Regulation

Moving to partially allay uncertainty regarding the approval of medical devices for use in their country, the government of the United Kingdom has reportedly passed regulations applicable to medical devices int... Read More...

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