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medical devices

FDA Proposes Labeling Submission Rules for Some Home-Use Medical Devices

In an effort to make information on the use of certain higher-risk home-use medical...

Batteries in Implantable Defibrillators May Fail

The U.S. Food and Drug Administration (FDA) and medical device manufacturer St. Jude Medical...

FDA Updates Draft Recommendations for 510(k) Device Modifications

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance to...

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...

Home Use Medical and Wellness Devices

Why are home use medical and wellness devices drawing so much attention and growing at an explosive rate?
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U.S. Marketing Authorization of Novel Medical Devices

Common FDA Regulatory Pathways for Uncommon Devices

Digital Hearing Aids: Designing for EMC Compliance

To protect the hearing health of hearing aid users, researchers in the relevant areas have been studying the effects of EMI on hearing aids.

Alere, Inc. Recalls INRatio Monitoring Systems

Alere, Inc. is voluntarily recalling their INRatio® and INRatio®2 PT/INR Monitoring System after working with the U.S. Food and Drug Administration (FDA).

FDA Seeks Comments on 3D Printing for Medical Devices

The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.

Towards a Logic-Based Extension of a Relational Software Tool for Coherent Technical Documentation of Medical Devices

This work presents a novel software tool intended to support compilation of coherent technical...
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