Sep 15, 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 total product lifecycle of infusion pumps. The document is intended to provide medical device...
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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 on design control for medical devices. The document provides additional clarifications and recommendations to be...
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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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Sep 13, 2021
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to advertisements and sales promotions of medical devices. The document is intended to provide medical device...
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Sep 13, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidelines describing recalls, corrections, and removals in the context of medical devices. The document is intended to...
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