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Presented by Pharmaceutical Care Management Association
With Emily Martin, Lauren Morello and Brianna Ehley
On Tap
but four members reject it, some citing pediatric concerns. European IP fight pits haves against have-nots
in coronavirus vaccine race.
A message from Pharmaceutical Care Management Association:
Center for Devices and Radiological Health
This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
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