Chapter 22-B105 - ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
- Rule 22-B10500 - WHO MUST REGISTER AND SUBMIT A DEVICE LIST
- Rule 22-B10501 - TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- Rule 22-B10502 - HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES
- Rule 22-B10503 - INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- Rule 22-B10504 - AMENDMENTS TO ESTABLISHMENT REGISTRATION
- Rule 22-B10505 - UPDATING DEVICE LISTING INFORMATION
- Rule 22-B10506 - ADDITIONAL LISTING INFORMATION
- Rule 22-B10507 - NOTIFICATION OF REGISTRANT
- Rule 22-B10508 - INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- Rule 22-B10509 - MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER
- Rule 22-B10510 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES
- Rule 22-B10511 - EXEMPTIONS FOR DEVICE ESTABLISHMENTS
- Rule 22-B10512 - WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED
- Rule 22-B10513 - EXEMPTION FROM PREMARKET NOTIFICATION
- Rule 22-B10514 - INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION
- Rule 22-B10515 - FORMAT OF A PREMARKET NOTIFICATION SUBMISSION
- Rule 22-B10516 - CONTENT AND FORMAT OF A 21 U.S.C. section 360(K) SUMMARY
- Rule 22-B10517 - CONTENT AND FORMAT OF A 21 U.S.C. section 360(K) STATEMENT
- Rule 22-B10518 - FORMAT OF A CLASS III CERTIFICATION
- Rule 22-B10519 - CONFIDENTIALITY OF INFORMATION
- Rule 22-B10520 - MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION
- Rule 22-B10521 - DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION
- Rule 22-B10599 - DEFINITIONS