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medical devices

FDA Releases Catalog of Regulatory Science Tools for Medical Devices

To facilitate the expanded use of innovative science techniques in the development of new...

FDA Posts Biocompatibility Resource Center

The U.S. Food and Drug Administration (FDA) has collected a variety of resources to...

UK Passes Post-Brexit Medical Device Regulation

Moving to partially allay uncertainty regarding the approval of medical devices for use in...

FDA Modifies List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

FDA Provides Update on ASCA Testing Laboratory Accreditation

The U.S. Food and Drug Administration (FDA) says it will release within the next...
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FDA Publishes Medical Device Shortage List

The U.S. Food and Drug Administration (FDA) has announced the publication of a medical...

FDA Names First Acting Director of Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has appointed its first Active Director of...

Keep your iPhone 12 Away from Medical Devices, Apple Says

iPhone maker Apple is cautioning certain users of its iPhone 12 models to be...

FDA Sets Action Plan to Regulate AI in Medical Devices

The U.S. Food and Drug Administration (FDA) has released its plan for regulating certain...

EU Commission Opens Options for Remote Audits for Medical Devices

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the European Union...
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