District of Columbia · Regulations
Chapter 22-B106 — PREMARKET APPROVAL OF MEDICAL DEVICES
34 sections
34 sections
- 22-B DCMR 1060010600. SCOPE
- 22-B DCMR 1060110601. PURPOSE
- 22-B DCMR 1060210602. CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE
- 22-B DCMR 1060310603. RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES
- 22-B DCMR 1060410604. SERVICE OF ORDERS
- 22-B DCMR 1060510605. PRODUCT DEVELOPMENT PROTOCOL (PDP)
- 22-B DCMR 1060610606. APPLICATION
- 22-B DCMR 1060710607. PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1060810608. PREMARKET APPROVAL APPLICATION SUPPLEMENTS
- 22-B DCMR 1060910609. TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061010610. FILING A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061110611. PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061210612. DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061310613. WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061410614. TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
- 22-B DCMR 1061510615. GENERAL
- 22-B DCMR 1061610616. POST-APPROVAL REQUIREMENTS
- 22-B DCMR 1061710617. REPORTS
- 22-B DCMR 1061810618. PURPOSE AND SCOPE
- 22-B DCMR 1061910619. DESIGNATION OF HUMANITARIAN USE DEVICES STATUS
- 22-B DCMR 1062010620. ORIGINAL APPLICATIONS
- 22-B DCMR 1062110621. HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS
- 22-B DCMR 1062210622. SUPPLEMENTAL APPLICATIONS
- 22-B DCMR 1062310623. NEW INDICATIONS FOR USE
- 22-B DCMR 1062410624. FILING A HUMANITARIAN DEVICE EXEMPTION
- 22-B DCMR 1062510625. TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION
- 22-B DCMR 1062610626. PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION
- 22-B DCMR 1062710627. DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
- 22-B DCMR 1062810628. TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
- 22-B DCMR 1062910629. CONFIDENTIALITY OF DATA AND INFORMATION
- 22-B DCMR 1063010630. [RESERVED]Reserved
- 22-B DCMR 1063110631. INSTITUTIONAL REVIEW BOARD REQUIREMENTS
- 22-B DCMR 1063210632. POST-APPROVAL REQUIREMENTS AND REPORTS
- 22-B DCMR 1069910699. DEFINITIONS