District of Columbia · Regulations
Chapter 22-B105 — ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
23 sections
23 sections
- 22-B DCMR 1050010500. WHO MUST REGISTER AND SUBMIT A DEVICE LIST
- 22-B DCMR 1050110501. TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- 22-B DCMR 1050210502. HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES
- 22-B DCMR 1050310503. INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- 22-B DCMR 1050410504. AMENDMENTS TO ESTABLISHMENT REGISTRATION
- 22-B DCMR 1050510505. UPDATING DEVICE LISTING INFORMATION
- 22-B DCMR 1050610506. ADDITIONAL LISTING INFORMATION
- 22-B DCMR 1050710507. NOTIFICATION OF REGISTRANT
- 22-B DCMR 1050810508. INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING
- 22-B DCMR 1050910509. MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER
- 22-B DCMR 1051010510. ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES
- 22-B DCMR 1051110511. EXEMPTIONS FOR DEVICE ESTABLISHMENTS
- 22-B DCMR 1051210512. WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED
- 22-B DCMR 1051310513. EXEMPTION FROM PREMARKET NOTIFICATION
- 22-B DCMR 1051410514. INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION
- 22-B DCMR 1051510515. FORMAT OF A PREMARKET NOTIFICATION SUBMISSION
- 22-B DCMR 1051610516. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) SUMMARY
- 22-B DCMR 1051710517. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) STATEMENT
- 22-B DCMR 1051810518. FORMAT OF A CLASS III CERTIFICATION
- 22-B DCMR 1051910519. CONFIDENTIALITY OF INFORMATION
- 22-B DCMR 1052010520. MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION
- 22-B DCMR 1052110521. DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION
- 22-B DCMR 1059910599. DEFINITIONS