Federal (United States) · Session law
Pub. L. 105-115 — To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.
77 sections
1 group
49 sections filed directly here
- Pub. L. 105-115, tit. I, sec. 201INVESTIGATIONAL DEVICE EXEMPTIONS.Enacted
- Pub. L. 105-115, tit. I, sec. 202SPECIAL REVIEW FOR CERTAIN DEVICES.Enacted
- Pub. L. 105-115, tit. I, sec. 203EXPANDING HUMANITARIAN USE OF DEVICES.Enacted
- Pub. L. 105-115, tit. I, sec. 204DEVICE STANDARDS.Enacted
- Pub. L. 105-115, tit. I, sec. 205SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS.Enacted
- Pub. L. 105-115, tit. I, sec. 206PREMARKET NOTIFICATION.Enacted
- Pub. L. 105-115, tit. I, sec. 207EVALUATION OF AUTOMATIC CLASS III DESIGNATION.Enacted
- Pub. L. 105-115, tit. I, sec. 208CLASSIFICATION PANELS.Enacted
- Pub. L. 105-115, tit. I, sec. 209CERTAINTY OF REVIEW TIMEFRAMES; COLLABORATIVE REVIEW PROCESS.Enacted
- Pub. L. 105-115, tit. I, sec. 210ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET NOTIFICATION REPORTS.Enacted
- Pub. L. 105-115, tit. I, sec. 211DEVICE TRACKING.Enacted
- Pub. L. 105-115, tit. I, sec. 212POSTMARKET SURVEILLANCE.Enacted
- Pub. L. 105-115, tit. I, sec. 213REPORTS.Enacted
- Pub. L. 105-115, tit. I, sec. 214PRACTICE OF MEDICINE.Enacted
- Pub. L. 105-115, tit. I, sec. 215NONINVASIVE BLOOD GLUCOSE METER.Enacted
- Pub. L. 105-115, tit. I, sec. 216USE OF DATA RELATING TO PREMARKET APPROVAL; PRODUCT DEVELOPMENT PROTOCOL.Enacted
- Pub. L. 105-115, tit. I, sec. 217CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL.Enacted
- Pub. L. 105-115, tit. I, sec. 301FLEXIBILITY FOR REGULATIONS REGARDING CLAIMS.Enacted
- Pub. L. 105-115, tit. I, sec. 302PETITIONS FOR CLAIMS.Enacted
- Pub. L. 105-115, tit. I, sec. 303HEALTH CLAIMS FOR FOOD PRODUCTS.Enacted
- Pub. L. 105-115, tit. I, sec. 304NUTRIENT CONTENT CLAIMS.Enacted
- Pub. L. 105-115, tit. I, sec. 305REFERRAL STATEMENTS.Enacted
- Pub. L. 105-115, tit. I, sec. 306DISCLOSURE OF IRRADIATION.Enacted
- Pub. L. 105-115, tit. I, sec. 307IRRADIATION PETITION.Enacted
- Pub. L. 105-115, tit. I, sec. 308GLASS AND CERAMIC WARE.Enacted
- Pub. L. 105-115, tit. I, sec. 309FOOD CONTACT SUBSTANCES.Enacted
- Pub. L. 105-115, tit. I, sec. 401DISSEMINATION OF INFORMATION ON NEW USES.Enacted
- Pub. L. 105-115, tit. I, sec. 402EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS.Enacted
- Pub. L. 105-115, tit. I, sec. 403APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.Enacted
- Pub. L. 105-115, tit. I, sec. 404DISPUTE RESOLUTION.Enacted
- Pub. L. 105-115, tit. I, sec. 405INFORMAL AGENCY STATEMENTS.Enacted
- Pub. L. 105-115, tit. I, sec. 406FOOD AND DRUG ADMINISTRATION MISSION AND ANNUAL REPORT.Enacted
- Pub. L. 105-115, tit. I, sec. 407INFORMATION SYSTEM.Enacted
- Pub. L. 105-115, tit. I, sec. 408EDUCATION AND TRAINING.Enacted
- Pub. L. 105-115, tit. I, sec. 409CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS.Enacted
- Pub. L. 105-115, tit. I, sec. 410MUTUAL RECOGNITION AGREEMENTS AND GLOBAL HARMONIZATION.Enacted
- Pub. L. 105-115, tit. I, sec. 411ENVIRONMENTAL IMPACT REVIEW.Enacted
- Pub. L. 105-115, tit. I, sec. 412NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.Enacted
- Pub. L. 105-115, tit. I, sec. 413FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.Enacted
- Pub. L. 105-115, tit. I, sec. 414INTERAGENCY COLLABORATION.Enacted
- Pub. L. 105-115, tit. I, sec. 415CONTRACTS FOR EXPERT REVIEW.Enacted
- Pub. L. 105-115, tit. I, sec. 416PRODUCT CLASSIFICATION.Enacted
- Pub. L. 105-115, tit. I, sec. 417REGISTRATION OF FOREIGN ESTABLISHMENTS.Enacted
- Pub. L. 105-115, tit. I, sec. 418CLARIFICATION OF SEIZURE AUTHORITY.Enacted
- Pub. L. 105-115, tit. I, sec. 419INTERSTATE COMMERCE.Enacted
- Pub. L. 105-115, tit. I, sec. 420SAFETY REPORT DISCLAIMERS.Enacted
- Pub. L. 105-115, tit. I, sec. 421LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY REQUIREMENTS.Enacted
- Pub. L. 105-115, tit. I, sec. 422RULE OF CONSTRUCTION.Enacted
- Pub. L. 105-115, tit. V, sec. 501EFFECTIVE DATE.Enacted