§801.3. Definitions. — Inbound Citations
21 C.F.R. § 801.3
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 801.3 as a whole
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(2) Purchases, arranges for or negotiates the purchase of a covered drug, device, biological, or medical supply for a group of individuals or entities, but not solely for use by the entity itself.Applicable manufacturer means an entity that is operating in the United States and that falls within one of the following categories:
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(iv) To exchange electronic health information with, and integrate such information from other sources; and