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medical devices

FDA User Fees for Medical Device Applications Slated to Increase

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has published an updated list of consensus...

CFDA May Require Chinese Translation of Foreign Medical Device Applications

The China Food and Drug Administration (CFDA) is reportedly considering a new regulation that...

FDA Plans to Revisit Regulations for Digital Health Products

The U.S. Food and Drug Administration (FDA) has announced its intention to revisit its...

Novo Nordisk Recalls Insulin Delivery Devices

Global healthcare company Novo Nordisk has initiated a recall of certain insulin cartridge holders...
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FDA Extends Compliance Date for UDI for Some Medical Devices

The U.S. Food and Drug Administration (FDA) has extended the deadline for certain low-risk...

Wireless Compliance for Medical Manufacturers 101

This article focuses on global wireless compliance. More specifically, it explains what to consider if you intend to certify your device with an integrated third-party module internationally.

Lead-less Pacemaker Uses Wireless Power

A new type of pacemaker runs without wires or a battery, and is completely changing medical technology.

Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.

Medical Device Testing Requirements for 510(k) Submissions

Clients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device. While testing requirements are easy to determine for some devices, other devices require intensive research.
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