Section 22-B10400. GENERAL

Section 22-B10401. PUBLIC AVAILABILITY OF REPORTS

Section 22-B10402. GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS

Section 22-B10403. [RESERVED]

Section 22-B10404. WHERE TO SUBMIT REPORTS

Section 22-B10405. ENGLISH REPORTING REQUIREMENT

Section 22-B10406. ELECTRONIC REPORTING

Section 22-B10407. REQUESTS FOR ADDITIONAL INFORMATION

Section 22-B10408. DISCLAIMERS

Section 22-B10409. WRITTEN MEDICAL DEVICE REPORT PROCEDURES

Section 22-B10410. FILES AND DISTRIBUTOR RECORDS

Section 22-B10411. EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS

Section 22-B10412. HOW TO REPORT ADVERSE EVENTS

Section 22-B10413. WHERE TO FIND REPORTING CODES USED WITH MEDICAL DEVICE REPORTS

Section 22-B10414. WHEN NOT TO FILE A REPORT

Section 22-B10415. INDIVIDUAL ADVERSE EVENT REPORTS: USER FACILITIES

Section 22-B10416. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES

Section 22-B10417. ANNUAL REPORTS

Section 22-B10418. INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS

Section 22-B10419. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS

Section 22-B10420. INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS

Section 22-B10421. INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS

Section 22-B10422. FIVE (5) - DAY REPORTS FOR MANUFACTURERS

Section 22-B10423. SUPPLEMENTAL REPORTS

Section 22-B10424. FOREIGN MANUFACTURERS

Section 22-B10499. DEFINITIONS