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FDA Issues Guidance on Laser Products

The U.S. Food and Drug Administration (FDA) has issued a guidance to clarify the...

FDA Issues Guidance on Medical X-Ray Devices and Conformity with IEC Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable...

FDA Issues Guidance on Premarket Submission Info on Performance Testing

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

U.S. FDA Issues Guidance on Medical Devices Containing Materials of Animal Origin

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

U.S. FDA Publishes Updated Checklist for PMA Reviews

The FDA has issued an updated version of its guidance on premarket approval (PMA) application submissions and reviews for medical devices.
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FDA Issues Guidance on Device Exemptions from Pre-Market Notification Requirements

The U.S. Food and Drug Administration (FDA) has issued a final guidance clarifying the...

U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug...

FDA Provides Pre-Certification Working Model

The partial shutdown of many federal agencies has apparently not stopped the U.S. Food...

U.S. FDA Posts MDSAP Stakeholder Presentations

The U.S. Food and Drug Administration (FDA) has now provided access to presentations from...

FDA Proposes Improvements in De Novo Pathway for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a proposed rule intended to...
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