Nov 29, 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 De Novo Classification requests and the way they impact the FDA review clock and goals. The document...
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Nov 22, 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 actions related to De Novo classification requests in the context of their effect on FDA review clock...
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Nov 16, 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 describing De Novo Classification Requests in the context of the effect on the FDA review clock and goals. The...
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Oct 22, 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 describing in detail the acceptance review for the requests submitted under the De Novo classification process....
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Oct 21, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published several guidance documents dedicated to the De Novo Classification Process. One of the documents provides a brief overview of the...
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