A
Here's the case:
A Drug/device combination product is regulated as a drug. The device portion and the drug portion R&D are done by the same organization. That R&D group functions as the "specification developer" for the device portion. If that's the only device-related activity that happens at that site, is it necessary to register that site as a device establishment? If so, classified how?
Discuss.
A Drug/device combination product is regulated as a drug. The device portion and the drug portion R&D are done by the same organization. That R&D group functions as the "specification developer" for the device portion. If that's the only device-related activity that happens at that site, is it necessary to register that site as a device establishment? If so, classified how?
Discuss.