Chapter: 22-B105
ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 

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


Click on a table header to re-sort the results.
Click on Chapter Number to display Sections.
Use Search Field to search by Keywords

Section Number Section Heading Latest Version Effective Date
22-B10500 WHO MUST REGISTER AND SUBMIT A DEVICE LIST View text 7/12/2013
22-B10501 TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING View text 7/12/2013
22-B10502 HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES View text 7/12/2013
22-B10503 INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING View text 7/12/2013
22-B10504 AMENDMENTS TO ESTABLISHMENT REGISTRATION View text 7/12/2013
22-B10505 UPDATING DEVICE LISTING INFORMATION View text 7/12/2013
22-B10506 ADDITIONAL LISTING INFORMATION View text 7/12/2013
22-B10507 NOTIFICATION OF REGISTRANT View text 7/12/2013
22-B10508 INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING View text 7/12/2013
22-B10509 MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER View text 7/12/2013
22-B10510 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES View text 7/12/2013
22-B10511 EXEMPTIONS FOR DEVICE ESTABLISHMENTS View text 7/12/2013
22-B10512 WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED View text 7/12/2013
22-B10513 EXEMPTION FROM PREMARKET NOTIFICATION View text 7/12/2013
22-B10514 INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION View text 7/12/2013
22-B10515 FORMAT OF A PREMARKET NOTIFICATION SUBMISSION View text 7/12/2013
22-B10516 CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) SUMMARY View text 7/12/2013
22-B10517 CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) STATEMENT View text 7/12/2013
22-B10518 FORMAT OF A CLASS III CERTIFICATION View text 7/12/2013
22-B10519 CONFIDENTIALITY OF INFORMATION View text 7/12/2013
22-B10520 MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION View text 7/12/2013
22-B10521 DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION View text 7/12/2013
22-B10599 DEFINITIONS View text 7/12/2013