District of Columbia · Regulations
Chapter 22-B104 — MEDICAL DEVICE REPORTING
26 sections
26 sections
- 22-B DCMR 1040010400. GENERAL
- 22-B DCMR 1040110401. PUBLIC AVAILABILITY OF REPORTS
- 22-B DCMR 1040210402. GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS
- 22-B DCMR 1040310403. RESERVED
- 22-B DCMR 1040410404. WHERE TO SUBMIT REPORTS
- 22-B DCMR 1040510405. ENGLISH REPORTING REQUIREMENT
- 22-B DCMR 1040610406. ELECTRONIC REPORTING
- 22-B DCMR 1040710407. REQUESTS FOR ADDITIONAL INFORMATION
- 22-B DCMR 1040810408. DISCLAIMERS
- 22-B DCMR 1040910409. WRITTEN MEDICAL DEVICE REPORT PROCEDURES
- 22-B DCMR 1041010410. FILES AND DISTRIBUTOR RECORDS
- 22-B DCMR 1041110411. EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS
- 22-B DCMR 1041210412. HOW TO REPORT ADVERSE EVENTS
- 22-B DCMR 1041310413. WHERE TO FIND REPORTING CODES USED WITH MEDICAL DEVICE REPORTS
- 22-B DCMR 1041410414. WHEN NOT TO FILE A REPORT
- 22-B DCMR 1041510415. INDIVIDUAL ADVERSE EVENT REPORTS: USER FACILITIES
- 22-B DCMR 1041610416. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES
- 22-B DCMR 1041710417. ANNUAL REPORTS
- 22-B DCMR 1041810418. INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS
- 22-B DCMR 1041910419. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS
- 22-B DCMR 1042010420. INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS
- 22-B DCMR 1042110421. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS
- 22-B DCMR 1042210422. FIVE (5) - DAY REPORTS FOR MANUFACTURERS
- 22-B DCMR 1042310423. SUPPLEMENTAL REPORTS
- 22-B DCMR 1042410424. FOREIGN MANUFACTURERS
- 22-B DCMR 1049910499. DEFINITIONS