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FDA Publishes Final Guidance on Software as a Medical Device

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

FDA Approves Remote Reprogramming of Cochlear Implant Device

In a first for the agency, the U.S. Food and Drug Administration (FDA) has...

FDA Issues Updated Guidance on Addressing Medical Device Changes

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

FDA Warns Medical Diagnostic Company of Violations

The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on...

FDA Names Digital Health Pilot Program Participants

The U.S. Food and Drug Administration (FDA) has selected nine companies to participate in...
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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 Plans to Revisit Regulations for Digital Health Products

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

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...
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