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Tag: Food and Drug Administration

FDA Guidance on Quantitative Imaging: Specific Aspects

The new article provides an overview of the specific regulatory requirements for quantitative imaging function in medical devices, including the aspects related to labeling,...

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FDA on Electromagnetic Compatibility of Medical Devices: Modifications and Labeling

The new article describes in detail specific aspects of electromagnetic compatibility, including the ones related to modifications and labeling.  Table of ContentsThe Food and...

FDA on Heater-Cooler Devices

The article provides an overview of the existing regulatory framework for heater-cooler devices. Table of ContentsThe Food and Drug Administration (FDA or the Agency),...

FDA Guidance on Electromagnetic Compatibility: Testing, Allowances, and Deviations

The article highlights specific aspects related to electromagnetic compatibility, including the ones associated with testing the products should undergo to ensure compliance with the...

FDA Guidance on Sterility Information: Overview

The article provides an overview of the regulatory requirements regarding the sterility information to be included in the premarket submission.  Table of ContentsThe Food...

FDA Guidance on Electromagnetic Compatibility: Standards and Testing

The new article describes in detail the scope of information to be included in the premarket submission concerning electromagnetic compatibility.  Table of ContentsThe Food...

FDA Guidance on Orthopedic Fracture Fixation Plates: Testing a Validation

The new article describes in detail the aspects related to specific testing performance criteria, including mechanical bench testing, sterilization, and reprocessing validation.  Table of...
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FDA Guidance on Electromagnetic Compatibility of Medical Devices: Overview

The article provides an overview of the US regulatory framework regarding the electromagnetic compatibility of medical devices.  Table of ContentsThe Food and Drug Administration...

FDA Guidance on Orthopedic Fracture Fixation Plates: Overview

The article provides a brief overview of the applicable regulatory requirements for orthopedic fracture fixation plates.  Table of ContentsThe Food and Drug Administration (FDA...

FDA Guidance on Quality System Information: Specific Aspects

The new article provides the details regarding certain specific aspects associated with the quality system information to be provided by the medical device manufacturer...

FDA Guidance on a Safer Technologies Program: Mechanisms for Feedback

The article describes in detail the mechanisms to be used by the authority to provide its feedback regarding the device development.  Table of ContentsThe...

FDA Guidance on STeP: Additional Considerations for Entrance Review

The new article highlights specific aspects related to the entrance review, the ones the authority will also assess when determining the eligibility of the...

FDA Guidance on Safer Technologies Program: Eligibility Factors

The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process. Table of ContentsThe Food and...
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