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Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
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Webinar Presentation and Transcript added to Final Guidance on Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
On Monday, August 8, 2016, the FDA will host a webinar to share information and answer questions about its final guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. This final guidance, issued on June 21, provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric…
Agenda posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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Class I Medical Device Recall: BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction
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Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery
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MedSun Newsletter #122 August 2016
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Webinar – Final Guidance on General Wellness: Policy for Low-Risk Devices
On September 1, the FDA will host a webinar to share information and answer questions for manufacturers about the final guidance document titled General Wellness: Policy for Low-Risk Devices. The guidance, issued on July 28, explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use….
Liquid Drug and Dietary Supplement Products by PharmaTech: Recall
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Executive Summary posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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