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Showing 251–263 of 263 regulations
Quality Management System Regulation
21 CFR Part 820 establishes Current Good Manufacturing Practice (CGMP) requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use. Manufacturers must establish and maintain a quality management system appropriate for their specific devices. The regulation applies to devices manufactured in the US or imported into the US, and covers manufacturers performing functions such as contract sterilization, relabeling, remanufacturing, and repacking. Blood components and certain other exempted products are excluded.
Control of Communicable Diseases
21 CFR Part 1240 establishes FDA regulations for controlling communicable diseases through sanitation and quarantine measures. The regulation defines key terms including communicable diseases, contamination, conveyances, garbage, incubation periods, and milk/milk products. It specifies requirements for interstate traffic involving conveyances and persons, and sets minimum heat treatment standards (boiling for 30+ minutes) for garbage in food-handling establishments including houses, restaurants, hotels, and kitchens.
Ophthalmic and Topical Dosage Form New Animal Drugs
This CFR regulation establishes specifications, sponsor information, and conditions of use for ophthalmic and topical dosage form new animal drugs, including amitraz, bacitracin-neomycin-polymyxin B combinations, buprenorphine, chloramphenicol, and chlorhexidine for veterinary use in dogs and cats. All drugs are restricted to use by or on the order of a licensed veterinarian.
Additional Standards for Miscellaneous Products
21 CFR Part 680 establishes standards for allergenic products used in diagnosis, prevention, or treatment of allergies. Requirements cover source material purity (max 1% foreign material), mold culture processing with approved standard operating procedures, and animal sourcing with veterinary oversight. Manufacturers must document mold identity, processing steps, contamination limits, and report specified animal diseases to the Center for Biologics Evaluation and Research.
Disposal
21 CFR Part 1317 establishes procedures for safe disposal of controlled substances by registered practitioners and other registrants. Authorized methods include on-site destruction, delivery to reverse distributors, return to manufacturers, or DEA assistance. Records and periodic reports to the DEA are required for regular disposals, with conditions set by the Special Agent in Charge to prevent diversion.
Exemptions from Federal Preemption of State and Local Medical Device Requirements
21 CFR Part 808 establishes procedures for states and localities to seek exemption from federal preemption of medical device requirements under the Federal Food, Drug, and Cosmetic Act. The FDA Commissioner may grant exemptions for state/local requirements that are either more stringent than federal standards or required by compelling local conditions, provided they do not conflict with federal law. General applicability requirements and those identical to federal standards remain non-preempted.
Implantation or Injectable Dosage Form New Animal Drugs
21 CFR Part 522 establishes specifications, sponsors, and conditions of use for injectable and implantation dosage form new animal drugs including acepromazine (tranquilizer/preanesthetic), alfaxalone (anesthetic), amikacin (antibiotic), and aminopentamide (anti-emetic/anti-diarrheal). Each drug section specifies dosage amounts for target species, indications for use, and limitations including veterinary-only restrictions and controlled substance designations where applicable.
Clinical Chemistry and Clinical Toxicology Devices
21 CFR Part 862 establishes the FDA classification framework for clinical chemistry and clinical toxicology devices intended for human use. It defines the scope of device regulation, specifies that calibrators used with these devices are classified as Class II regardless of the device's classification due to their critical role in measurement accuracy, and outlines the premarket approval requirements and effective dates for devices classified as Class III.
General
21 CFR Part 800 establishes sterility and tamper-resistant packaging requirements for contact lens solutions and ophthalmic medical devices. All contact lens solutions, eye cups, and similar ophthalmic preparations must be sterile at the time of filling and closing, with appropriate labeling and warnings. Multiple-dose containers must contain preservatives or be labeled with duration limits. Products failing to meet these standards are considered adulterated or misbranded.
Premarket Approval of Medical Devices
21 CFR Part 814 establishes the premarket approval (PMA) process for Class III medical devices intended for human use. The regulation defines procedures for FDA review to ensure devices are safe and effective before market introduction, applies to devices not on the market before May 1976 or those required by regulation to obtain PMA approval, and sets conditions for approval and supplemental applications.
Performance Standards for Light-Emitting Products
FDA performance standards for laser products manufactured after August 1, 1976, establishing safety classifications (Class I, IIa, II, etc.) and accessible emission limits to protect human exposure to laser radiation. Manufacturers must register products, provide warning labels and safe installation instructions, and maintain distribution records.
Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
This regulation establishes registration requirements for manufacturers, distributors, importers, and exporters of List I chemicals under DEA jurisdiction. Registration is mandatory for entities handling ephedrine, pseudoephedrine, phenylpropanolamine, and other designated List I chemicals. Annual fees apply: $3,699 for manufacturers and $1,850 for distributors, importers, and exporters. Registration must be submitted online via the DEA's secure portal with payment by ACH transfer or credit card. Separate registrations are required for independent activities (manufacturing, distributing, importing, exporting).
Orders for Schedule I and II Controlled Substances
This regulation establishes procedures for ordering Schedule I and II controlled substances under the Controlled Substances Act. It specifies who may obtain DEA Form 222 or issue electronic orders (registered persons only), exemptions from ordering requirements, and authorization procedures including power of attorney provisions for agents to execute orders on behalf of registrants.