D.C. Mun. Regs. tit. 22-B, ch. 106 – Premarket Approval of Medical Devices | Midpage

Collections
District of Columbia Municipal Regulations

Chapter 22-B106

D.C. Mun. Regs. tit. 22-B, ch. 106

Premarket Approval of Medical Devices

District of Columbia, Office of the Secretary

22-B10600Scope 22-B10601Purpose 22-B10602Confidentiality of Data and Information in a Premarket Approval Application (PMA) File 22-B10603Research Conducted Outside of the United States 22-B10604Service of Orders 22-B10605Product Development Protocol (PDP)22-B10606Application 22-B10607Premarket Approval Application Amendments and Resubmitted Premarket Approval Application 22-B10608Premarket Approval Application Supplements 22-B10609Time Frame for Reviewing a Premarket Approval Application 22-B10610Filing a Premarket Approval Application 22-B10611Procedures for Review of a Premarket Approval Application 22-B10612Denial of Approval of a Premarket Approval Application 22-B10613Withdrawal of Approval of a Premarket Approval Application 22-B10614Temporary Suspension of Approval of a Premarket Approval Application 22-B10615General 22-B10616Post-approval Requirements 22-B10617Reports 22-B10618Purpose and Scope 22-B10619Designation of Humanitarian Use Devices Status 22-B10620Original Applications 22-B10621Humanitarian Device Exemption Amendments and Resubmitted Humanitarian Device Exemptions 22-B10622Supplemental Applications 22-B10623New Indications for Use 22-B10624Filing a Humanitarian Device Exemption 22-B10625Time Frames for Reviewing a Humanitarian Device Exemption 22-B10626Procedures for Review of a Humanitarian Device Exemption 22-B10627Denial of Approval or Withdrawal of Approval of a Humanitarian Device Exemption 22-B10628Temporary Suspension of Approval of a Humanitarian Device Exemption 22-B10629Confidentiality of Data and Information 22-B10630[Reserved]22-B10631Institutional Review Board Requirements 22-B10632Post-approval Requirements and Reports 22-B10699Definitions