Medical Innovation Exchange

Final Guidance

FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions

FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions     The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. It …

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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices

Final Guidance for Submission of Off-The-Shelf Software in Medical Devices     On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation …

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FDA Releases Final Guidance on Premarket Submissions for Device Software Functions

FDA Releases Final Guidance on Premarket Submissions for Device Software Functions     The FDA has released a final guidance on premarket submissions for device software functions. “Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. This …

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FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices

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

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

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

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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