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U.S. Food and Drug Administration (FDA)

FDA Establishes Pre-Market Approval Pilot Program

As part of its effort to streamline the approval process for high-risk 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...

FDA Releases Digital Health Innovation Plan

In an effort to facilitate greater market access for new and advanced healthcare technologies,...

FDA Plans to Revisit Regulations for Digital Health Products

The U.S. Food and Drug Administration (FDA) has announced its intention to revisit its...
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Novo Nordisk Recalls Insulin Delivery Devices

Global healthcare company Novo Nordisk has initiated a recall of certain insulin cartridge holders...

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...

FDA Exempts 70 Plus Class I Devices from 510(k) Premarket Notification

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

FDA Proposes Exempting Some Class II Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices...

FDA Issues Final Guidance on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has issued a final version of its...
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