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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B106. PREMARKET APPROVAL OF MEDICAL DEVICES |
| Section 22-B10600. SCOPE |
| Section 22-B10601. PURPOSE |
| Section 22-B10602. CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE |
| Section 22-B10603. RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES |
| Section 22-B10604. SERVICE OF ORDERS |
| Section 22-B10605. PRODUCT DEVELOPMENT PROTOCOL (PDP) |
| Section 22-B10606. APPLICATION |
| Section 22-B10607. PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION |
| Section 22-B10608. PREMARKET APPROVAL APPLICATION SUPPLEMENTS |
| Section 22-B10609. TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION |
| Section 22-B10610. FILING A PREMARKET APPROVAL APPLICATION |
| Section 22-B10611. PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION |
| Section 22-B10612. DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION |
| Section 22-B10613. WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION |
| Section 22-B10614. TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION |
| Section 22-B10615. GENERAL |
| Section 22-B10616. POST-APPROVAL REQUIREMENTS |
| Section 22-B10617. REPORTS |
| Section 22-B10618. PURPOSE AND SCOPE |
| Section 22-B10619. DESIGNATION OF HUMANITARIAN USE DEVICES STATUS |
| Section 22-B10620. ORIGINAL APPLICATIONS |
| Section 22-B10621. HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS |
| Section 22-B10622. SUPPLEMENTAL APPLICATIONS |
| Section 22-B10623. NEW INDICATIONS FOR USE |
| Section 22-B10624. FILING A HUMANITARIAN DEVICE EXEMPTION |
| Section 22-B10625. TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION |
| Section 22-B10626. PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION |
| Section 22-B10627. DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION |
| Section 22-B10628. TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION |
| Section 22-B10629. CONFIDENTIALITY OF DATA AND INFORMATION |
| Section 22-B10630. [RESERVED] |
| Section 22-B10631. INSTITUTIONAL REVIEW BOARD REQUIREMENTS |
| Section 22-B10632. POST-APPROVAL REQUIREMENTS AND REPORTS |
| Section 22-B10699. DEFINITIONS |