Chapter: 22-B106
PREMARKET APPROVAL OF MEDICAL DEVICES 

Title: 22 HEALTH
SubTitle: 22-B PUBLIC HEALTH AND MEDICINE


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Section Number Section Heading Latest Version Effective Date
22-B10600 SCOPE View text 7/12/2013
22-B10601 PURPOSE View text 7/12/2013
22-B10602 CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE View text 7/12/2013
22-B10603 RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES View text 7/12/2013
22-B10604 SERVICE OF ORDERS View text 7/12/2013
22-B10605 PRODUCT DEVELOPMENT PROTOCOL (PDP) View text 7/12/2013
22-B10606 APPLICATION View text 7/12/2013
22-B10607 PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10608 PREMARKET APPROVAL APPLICATION SUPPLEMENTS View text 7/12/2013
22-B10609 TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10610 FILING A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10611 PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10612 DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10613 WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10614 TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION View text 7/12/2013
22-B10615 GENERAL View text 7/12/2013
22-B10616 POST-APPROVAL REQUIREMENTS View text 7/12/2013
22-B10617 REPORTS View text 7/12/2013
22-B10618 PURPOSE AND SCOPE View text 7/12/2013
22-B10619 DESIGNATION OF HUMANITARIAN USE DEVICES STATUS View text 7/12/2013
22-B10620 ORIGINAL APPLICATIONS View text 7/12/2013
22-B10621 HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS View text 7/12/2013
22-B10622 SUPPLEMENTAL APPLICATIONS View text 7/12/2013
22-B10623 NEW INDICATIONS FOR USE View text 7/12/2013
22-B10624 FILING A HUMANITARIAN DEVICE EXEMPTION View text 7/12/2013
22-B10625 TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION View text 7/12/2013
22-B10626 PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION View text 7/12/2013
22-B10627 DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION View text 7/12/2013
22-B10628 TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION View text 7/12/2013
22-B10629 CONFIDENTIALITY OF DATA AND INFORMATION View text 7/12/2013
22-B10630 [RESERVED] View text 7/12/2013
22-B10631 INSTITUTIONAL REVIEW BOARD REQUIREMENTS View text 7/12/2013
22-B10632 POST-APPROVAL REQUIREMENTS AND REPORTS View text 7/12/2013
22-B10699 DEFINITIONS View text 7/12/2013