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Srivaths Kalyan Ph.D on Muck Rack

Srivaths Kalyan Ph.D

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New Guidance On PCCPs Expanded To Include All Medical Devices

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By Marta Villarraga, Surya Sharma Ph.D, Kaitlin Alexander, Srivaths Kalyan Ph.D
| Mondaq
The Food and Drug Administration recently issued new draft guidance, Predetermined Change Control Plans for Medical Devices, that allows predetermined change control plans (PCCPs) for all medical devices, in contrast to the 2023 draft guidance that was limited to PCCPs for artificial intelligence/machine learning enabled-devices.
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