Federal (United States) · Session law
Pub. L. 107-250 — To amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes.
25 sections
25 sections
- Pub. L. 107-250, tit. I, sec. 101FINDINGS.Enacted
- Pub. L. 107-250, tit. I, sec. 102ESTABLISHMENT OF PROGRAM.Enacted
- Pub. L. 107-250, tit. I, sec. 103ANNUAL REPORTS.Enacted
- Pub. L. 107-250, tit. I, sec. 104POSTMARKET SURVEILLANCE.Enacted
- Pub. L. 107-250, tit. I, sec. 105CONSULTATION.Enacted
- Pub. L. 107-250, tit. I, sec. 106EFFECTIVE DATE.Enacted
- Pub. L. 107-250, tit. I, sec. 107SUNSET CLAUSE.Enacted
- Pub. L. 107-250, tit. II, sec. 201INSPECTIONS BY ACCREDITED PERSONS.Enacted
- Pub. L. 107-250, tit. II, sec. 202THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.Enacted
- Pub. L. 107-250, tit. II, sec. 203DEBARMENT OF ACCREDITED PERSONS.Enacted
- Pub. L. 107-250, tit. II, sec. 204DESIGNATION AND REGULATION OF COMBINATION PRODUCTS.Enacted
- Pub. L. 107-250, tit. II, sec. 205REPORT ON CERTAIN DEVICES.Enacted
- Pub. L. 107-250, tit. II, sec. 206ELECTRONIC LABELING.Enacted
- Pub. L. 107-250, tit. II, sec. 207ELECTRONIC REGISTRATION.Enacted
- Pub. L. 107-250, tit. II, sec. 208INTENDED USE.Enacted
- Pub. L. 107-250, tit. II, sec. 209MODULAR REVIEW.Enacted
- Pub. L. 107-250, tit. II, sec. 210PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF PREMARKET APPLICATIONS.Enacted
- Pub. L. 107-250, tit. II, sec. 211INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM REQUIREMENT OF PREMARKET NOTIFICATION.Enacted
- Pub. L. 107-250, tit. II, sec. 212STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING PEDIATRIC POPULATIONS.Enacted
- Pub. L. 107-250, tit. II, sec. 213GUIDANCE REGARDING PEDIATRIC DEVICES.Enacted
- Pub. L. 107-250, tit. II, sec. 214BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL.Enacted
- Pub. L. 107-250, tit. II, sec. 215BREAST IMPLANTS; RESEARCH THROUGH NATIONAL INSTITUTES OF HEALTH.Enacted
- Pub. L. 107-250, tit. III, sec. 301IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.Enacted
- Pub. L. 107-250, tit. III, sec. 302SINGLE-USE MEDICAL DEVICES.Enacted
- Pub. L. 107-250, tit. III, sec. 303MEDWATCH.Enacted