Chapter 22-B106 - PREMARKET APPROVAL OF MEDICAL DEVICES

Rule 22-B10600 - SCOPE
Rule 22-B10601 - PURPOSE
Rule 22-B10602 - CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE
Rule 22-B10603 - RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES
Rule 22-B10604 - SERVICE OF ORDERS
Rule 22-B10605 - PRODUCT DEVELOPMENT PROTOCOL (PDP)
Rule 22-B10606 - APPLICATION
Rule 22-B10607 - PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION
Rule 22-B10608 - PREMARKET APPROVAL APPLICATION SUPPLEMENTS
Rule 22-B10609 - TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION
Rule 22-B10610 - FILING A PREMARKET APPROVAL APPLICATION
Rule 22-B10611 - PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION
Rule 22-B10612 - DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
Rule 22-B10613 - WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
Rule 22-B10614 - TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION
Rule 22-B10615 - GENERAL
Rule 22-B10616 - POST-APPROVAL REQUIREMENTS
Rule 22-B10617 - REPORTS
Rule 22-B10618 - PURPOSE AND SCOPE
Rule 22-B10619 - DESIGNATION OF HUMANITARIAN USE DEVICES STATUS
Rule 22-B10620 - ORIGINAL APPLICATIONS
Rule 22-B10621 - HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS
Rule 22-B10622 - SUPPLEMENTAL APPLICATIONS
Rule 22-B10623 - NEW INDICATIONS FOR USE
Rule 22-B10624 - FILING A HUMANITARIAN DEVICE EXEMPTION
Rule 22-B10625 - TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION
Rule 22-B10626 - PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION
Rule 22-B10627 - DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
Rule 22-B10628 - TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION
Rule 22-B10629 - CONFIDENTIALITY OF DATA AND INFORMATION
Rule 22-B10630 - RESERVED
Rule 22-B10631 - INSTITUTIONAL REVIEW BOARD REQUIREMENTS
Rule 22-B10632 - POST-APPROVAL REQUIREMENTS AND REPORTS
Rule 22-B10699 - DEFINITIONS