Sep 20, 2023
FDA
The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...
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Sep 19, 2023
FDA
This article describes in detail the approach to be applied with respect to computational modeling and engineering analysis to be conducted in the course of non-clinical testing of the products in order to assess their materials and characteristics. Table of Contents...
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May 28, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document describing how a responsible entity can determine whether a software change to a medical device already placed on the...
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Apr 20, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has announced regulatory flexibilities for certain medical devices. The appropriate notice has been published on the official website of the Federal...
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Apr 19, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the specific criteria applied by the Agency when determining whether a 510(k) Premarket Notification...
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