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Tag: PMA

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Read the guidance The final guidance: Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol. Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing. Provides consensus standard references and terminology to aid […]

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body: premarket approval applications (PMAs), humanitarian device exemption […]

Recently Posted FDA Guidance Documents

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed┬áthis document┬áto describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

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