Aug 11, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support...
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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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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 describing the current policy for device software functions and mobile medical applications. The scope of the...
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Jun 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 dedicated to software validation. The document describes the general principles to be applied and also provides...
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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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