US FDA Roundup: Final Rules for Combination Products, Patient Reports for Medical Device Evaluation
Medical device manufacturers and sponsors, learn more at Emergo by UL about FDA rules on combination products; patient input on medical device evaluations and clinical studies so you can get to market approval faster.
US FDA Readies Transition Plans for COVID-19 Medical Device Enforcement Policies
New guidance from the US Food and Drug Administration explains a phased transition plan for medical devices currently covered by agency enforcement policies devised to address the COVID-19 public health emergency.
US FDA Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices
US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.
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