Apr 17, 2022
FDA
The new article highlights the aspects related to the requests for performance data in the context of 510(k) submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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Apr 12, 2022
FDA
The new article describes in detail the aspects related to technical characteristics and the way they should be treated in the context of substantial equivalence under the 510(k) framework. Table of Contents The Food and Drug...
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Sep 14, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to deciding when to submit a 510(k) for a software change to an existing device. Table of Contents The...
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Aug 10, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to deciding whether the software changes to a medical device already placed on the market require a new...
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Jun 24, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to deciding when to submit a 510(k) for a software change to an existing...
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