§860.220. De Novo request content. — Inbound Citations
21 C.F.R. § 860.220
Statutory Authority
Cited by 1 regulation in release Current.
Citations to §860.220(a)(3)
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(v) The requester has not responded to, or has failed to provide a rationale for not responding to, deficiencies identified by FDA in previous submissions for the same device, including those submissions described in § 860.220(a)(3).