§803.30. If I am a user facility, what reporting requirements apply to me? — Inbound Citations
21 C.F.R. § 803.30
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 803.30 as a whole
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(2) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 803.30; or
Citations to §803.30(b)
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You must include the following information in your report, if reasonably known to you, as described in § 803.30(b). These types of information correspond generally to the elements of Form FDA 3500A: