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

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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

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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

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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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