Final Guidance Archives - Medical Innovation Exchange

FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices

Leave a Comment / animal studies, device evaluation, Final Guidance, Medical Device, MedTech, premarket submissions, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By Inga Hansen

FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices On March 28, the FDA issued a final guidance, General Considerations for Animal Studies Intended to Evaluate Medical Devices, to assist medical device sponsors, testing facilities, and others involved in designing, conducting, and reporting the results of animal studies intended to assess the safety …

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FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products

Leave a Comment / confocal microscopy, exemptions, Final Guidance, lasers, Medical Device, MedTech, Quality/Regulatory, RC - Quality & Regulatory Market Access Solutions, research, SLA, variations / By Inga Hansen

FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products On January 30, the FDA issued its final guidance on Surveying, Leveling, and Alignment (SLA) Laser Products for manufacturers of laser products. The final guidance outlines the FDA’s approach on the applicability of the FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) …

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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

Leave a Comment / electromagnetic compatibility, Final Guidance, IVDR, Medical Device, MedTech, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, regulatory / By Inga Hansen

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …

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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

Leave a Comment / counterfeit device, FD&C Act, Final Guidance, Medical Device, MedTech, Quality/Regulatory, RC - Medical Device Audits, Certification & Verification, regulatory documents / By Inga Hansen

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …

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FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices

FDA Issues Final Guidance on Surveying, Leveling, and Alignment Laser Products

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

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