عرض 551–600 من أصل 648 لائحة
Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
21 CFR Part 630 establishes minimum criteria for blood and blood component donations intended for transfusion or further manufacturing. Blood establishments must determine donor eligibility, assess donation suitability, and notify deferred donors. The regulation defines key terms including blood, blood components, donors, and relevant transfusion-transmitted infections (HIV, HBV, HCV, HTLV, syphilis, West Nile virus, Chagas disease, CJD, vCJD, and malaria). Requirements apply to establishments manufacturing blood and blood components.
Mandatory Declassification Review
This regulation establishes procedures for mandatory declassification review of classified information held by the Office of National Drug Control Policy (ONDCP). It outlines how requests are submitted to the Security Officer, how ONDCP reviews and determines whether to declassify information under Executive Order 12356, and provides an appeal process to the ONDCP Director for denied requests. Information classified by other agencies is referred to those agencies for review. No fees are charged for these reviews.
Medical Devices; Reports of Corrections and Removals
21 CFR Part 806 establishes requirements for medical device manufacturers and importers to report corrections and removals to the FDA. Device manufacturers must promptly report actions that reduce health risks or remedy violations of the Federal Food, Drug, and Cosmetic Act, while maintaining records of all corrections and removals. Exempt actions include performance improvements that do not reduce health risk, market withdrawals, routine servicing, and stock recovery.
DEA Mailing Addresses
This regulation provides the official mailing addresses for the Drug Enforcement Administration (DEA) to be used when submitting correspondence and documents to the agency.
Performance Standards for Microwave and Radio Frequency Emitting Products
This regulation establishes performance standards for microwave ovens manufactured after October 6, 1971, setting limits on microwave radiation emission and requiring safety interlocks. Microwave ovens must not exceed 1 milliwatt per square centimeter power density at 5+ centimeters from the external surface before purchase, and 5 milliwatts per square centimeter thereafter. Devices must have at least two operative safety interlocks designed to prevent microwave generation when cavity access is possible, with at least one interlock resistant to human body contact and magnetic manipulation.
Required Warnings for Cigarette Packages and Advertisements
This regulation establishes requirements for warning labels on cigarette packages and advertisements sold in the United States. It defines key terms including cigarette, manufacturer, distributor, and retailer, and clarifies that retailers are not liable for compliant packaging supplied by licensed manufacturers, though they remain responsible for advertisements they display or alter.
Schedules of Controlled Substances
21 CFR Part 1308 establishes the schedules of controlled substances under the Controlled Substances Act, assigning DEA code numbers to opiates, opium derivatives, hallucinogenic substances, depressants, and other controlled drugs for identification and registration purposes. Applicants for procurement quotas, import/export permits, and registrants handling controlled substances must reference the appropriate code numbers on applications and declarations.
Repurchase, Repairs, or Replacement of Electronic Products
CFR Part 1004 establishes manufacturer obligations for electronic products that fail to comply with federal standards or have defects. Manufacturers must repair and bring products into conformity, replace them with equivalent compliant products, or refund the purchase price at no cost to consumers, including reimbursement for transportation. Manufacturers must submit detailed plans to the Secretary for approval before executing repairs or replacements.
Food Additives
21 CFR Part 570 establishes regulatory definitions and provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. It defines food additives as substances not exempted that become food components or affect food characteristics, including packaging materials with migration potential. The regulation outlines safety standards, requiring reasonable certainty of harmlessness based on scientific procedures, and addresses general recognition of safety, cumulative dietary effects, and prior sanctions.
Extralabel Drug Use in Animals
21 CFR Part 530 establishes conditions for extralabel use of FDA-approved drugs in animals by licensed veterinarians. Extralabel use—employing approved drugs in species, indications, dosages, or routes not on the label—is permitted only when animal health is threatened and within a valid veterinary-client-patient relationship. The rule prohibits advertising extralabel uses and requires veterinary records for FDA oversight and public health protection.
Medical Device Tracking Requirements
21 CFR Part 821 establishes mandatory tracking requirements for class II and III medical devices that meet FDA criteria, including those likely to cause serious adverse health consequences, implanted for over one year, or used as life-sustaining/supporting devices outside facilities. Manufacturers must trace devices from production through distributors to patients; failure to comply constitutes misbranding and a prohibited act. Manufacturers bear primary responsibility and must notify FDA if discontinuing business, with tracking records transferred or responsibility reassigned in writing.
Anesthesiology Devices
21 CFR Part 868 establishes the FDA classification framework for anesthesiology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements for Class III devices, defines substantial equivalence standards for premarket notification submissions, and specifies effective dates for FDA approval orders. Manufacturers must demonstrate substantial equivalence to existing devices or obtain premarket approval (PMA) or product development protocol (PDP) clearance before commercial distribution.
Radiology Devices
21 CFR Part 892 establishes the regulatory framework for radiology devices intended for human use in commercial distribution. The regulation sets out device classification requirements, premarket approval procedures, and exemption limitations. Manufacturers must demonstrate substantial equivalence to existing devices and comply with FDA approval requirements based on device class, with specific grace periods and effective dates governing commercial distribution of new or substantially altered radiology devices.
Labeling
FDA regulation 21 CFR Part 801 establishes labeling requirements for medical devices in package form. Manufacturers, packers, and distributors must conspicuously display their name and place of business (including street address, city, state, and ZIP code) on device labels. Labels must clarify the relationship between the labeled entity and the device (e.g., "Manufactured for", "Distributed by"). The regulation defines key terms including implantable devices, finished devices, expiration dates, and automatic identification and data capture (AIDC) technology for unique device identification.
Medical Device Recall Authority
21 CFR Part 810 establishes FDA procedures for exercising medical device recall authority under the Federal Food, Drug, and Cosmetic Act. It defines key terms including recall, correction, removal, serious adverse health consequences, and unique device identifiers, and outlines requirements for cease distribution orders and mandatory recall strategies applicable to device manufacturers, distributors, and user facilities.
Orthopedic Devices
21 CFR Part 888 establishes FDA classification and regulatory requirements for orthopedic devices intended for human use in commercial distribution. Devices classified as Class III require premarket approval (PMA) or completed product development protocol (PDP) before marketing, with specific effective dates and grace periods outlined. Manufacturers must demonstrate substantial equivalence to existing devices via premarket notification submissions.
Cardiovascular Devices
21 CFR Part 870 establishes FDA classification and regulatory requirements for cardiovascular devices intended for human use. The regulation outlines premarket approval (PMA) requirements for Class III devices, substantially equivalent device determinations under 510(k) submissions, and effective dates for compliance. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA premarket approval before commercial distribution, with grace periods specified for devices classified before May 28, 1976.
New Animal Drugs for Minor Use and Minor Species
This regulation (21 CFR Part 516) establishes procedures for designating and approving new animal drugs for minor uses and minor species, implementing section 573 of the Federal Food, Drug, and Cosmetic Act. It defines key terms including minor use, minor species, major species, MUMS drugs, and requirements for demonstrating functional superiority. The rule governs various dosage forms including oral, injectable, ophthalmic, topical, and feed-based formulations for animals other than humans or major livestock species.
Regulations Under the Federal Caustic Poison Act
21 CFR Part 1230 establishes labeling and packaging requirements for caustic and corrosive substances shipped in interstate or foreign commerce. Containers must bear clear labels with the common name of the dangerous substance, prominent "Poison" warnings in 24-point Gothic capitals, and directions for medical treatment in case of internal or external injury. Labeling must be firmly affixed and readily visible. Manufacturers, wholesalers, and distributors are responsible for compliance, with limited exemptions for non-household containers at shipment.
Postmarket Surveillance
21 CFR Part 822 establishes postmarket surveillance requirements for class II and III medical devices under the Federal Food, Drug, and Cosmetic Act. Manufacturers must implement surveillance plans for devices where failure poses serious health risks, are implanted long-term, support life outside healthcare facilities, or have significant pediatric use. The regulation defines key terms, responsibilities of designated persons and investigators, and procedures for collecting, analyzing, and reporting safety data to protect public health.
New Animal Drugs for Investigational Use
This regulation establishes exemptions from FDA approval requirements for new animal drugs intended solely for investigational use, including in vitro laboratory tests and clinical trials in animals. Distributors must ensure proper labeling, maintain records of shipments for two years, and verify that recipients are conducting legitimate research. Edible products from investigational animals cannot enter the food supply without FDA or USDA authorization.
Unique Device Identification
21 CFR Part 830 establishes requirements for unique device identification (UDI) of medical devices. The regulation defines key terms including UDI, device identifier, production identifier, labeler, and automatic identification and data capture (AIDC) technology. UDIs must adequately identify devices through distribution and use, comprising a fixed device identifier and conditional production identifier elements such as lot/batch number, serial number, expiration date, or manufacturing date. The Global Unique Device Identification Database (GUDID) serves as the repository for device identification information.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Controls to Satisfy the Requirements of the Act Applicable to the Manufacturing of Marihuana
21 CFR Part 1318 establishes regulatory controls for the registration and manufacturing of marihuana, including cultivation, growth, and harvest procedures. Registered manufacturers must deliver their total cannabis crops to the Administration within four months of harvest, with the Administration taking physical possession and controlling access. Applicants must demonstrate compliance with statutory requirements and public interest considerations under the Controlled Substances Act and international Single Convention obligations.
Prescriptions
21 CFR Part 1306 establishes procedures for prescribing and dispensing controlled substances to patients. It defines who may issue prescriptions (authorized individual practitioners), requires prescriptions be issued for legitimate medical purposes in the usual course of professional practice, and sets forth prescription format requirements including patient/practitioner information and drug details. Special provisions apply to Schedule III-V narcotic drugs used for maintenance or detoxification treatment.
Records and Reports of Registrants
21 CFR Part 1304 establishes recordkeeping and reporting requirements for registrants under the Controlled Substances Act, including manufacturers, distributors, importers, researchers, and practitioners. Registrants must maintain inventories and file reports as required by the Act; individual practitioners have limited recordkeeping obligations except for maintenance or detoxification treatments. Records may be consolidated into one system covering all controlled substance activities conducted under a single registration.
Quotas
This regulation establishes procedures for DEA quotas on Schedule I and II controlled substances. It defines three quota types—aggregate production, individual manufacturing, and procurement—and five subcategories covering commercial sale, transfers, product development, and replacement of disposed material. Quotas limit the total and per-manufacturer quantities of controlled substance APIs that may be produced or procured annually for pharmaceutical manufacturing.
Obstetrical and Gynecological Devices
21 CFR Part 884 establishes the regulatory framework for obstetrical and gynecological devices in commercial distribution. It outlines device classification procedures, premarket approval requirements under FDA section 515, and distinguishes between devices marketed before and after May 28, 1976. Manufacturers must demonstrate substantial equivalence for premarket notifications, and Class III devices require FDA approval before commercial distribution unless exempted.
Dental Devices
21 CFR Part 872 establishes the FDA classification framework for dental devices intended for human use in commercial distribution. It outlines scope, substantially equivalent device determinations, and premarket approval requirements for Class III devices, with grace periods and exemptions specified under the Federal Food, Drug, and Cosmetic Act.
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.
Requirements for Electronic Orders and Prescriptions
21 CFR Part 1311 establishes requirements for electronic orders and prescriptions of controlled substances, particularly Schedule I and II drugs. It mandates that electronic transmission systems meet authentication, nonrepudiation, and message integrity standards, with digital signatures using Public Key Infrastructure (PKI) technology identified as compliant. The regulation incorporates by reference cryptographic security standards from NIST, including FIPS publications 140-2, 180-2, and 180-3.
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).
Physical Medicine Devices
21 CFR Part 890 establishes the FDA classification framework for physical medicine devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including class III device approval timelines and substantial equivalence determinations. Manufacturers must demonstrate why their devices are substantially equivalent to existing devices and comply with applicable premarket notification procedures under 21 CFR Part 807.
Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
21 CFR Part 607 establishes establishment registration and product listing requirements for manufacturers of human blood and blood products, as well as manufacturers of licensed devices and biological products used in device manufacturing. The regulation defines key terms including blood products, establishments, manufacturing processes, and commercial distribution, and applies to blood banks, plasma donor centers, transfusion services, and independent testing laboratories.
Licensing
21 CFR Part 601 establishes procedures for obtaining biologics licenses from the FDA for biological products including therapeutic DNA plasmids, synthetic peptides, monoclonal antibodies, and recombinant DNA-derived products. Applicants must submit comprehensive safety, purity, and potency data from nonclinical and clinical studies, manufacturing information, stability data, labeling specimens, and environmental assessments to the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research.
Additional Standards for Human Blood and Blood Products
21 CFR Part 640 establishes manufacturing and quality standards for human whole blood and blood products intended for transfusion. Requirements cover donor examination, blood collection using sterile pyrogen-free containers with approved anticoagulants, storage at 1–6 °C, labeling, tamper-proof sealing, and aseptic processing to prevent contamination. Licensed establishments must supervise all manufacturing steps including donor identification, laboratory testing, and reissue conditions.
Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589 establishes prohibitions on substances in animal food and feed that present potential health risks or lack adequate safety data. The regulation prohibits gentian violet in all animal feed and propylene glycol in cat food, and restricts mammalian proteins in ruminant feed to prevent disease transmission. Violations render animal feed adulterated under the Federal Food, Drug, and Cosmetic Act.
Food Substances Affirmed as Generally Recognized as Safe in Feed and Drinking Water of Animals
This regulation affirms certain food substances as generally recognized as safe (GRAS) for use in animal feed and drinking water. Specific substances listed include ethyl alcohol with ethyl acetate as an energy source in ruminant supplements, hydrophobic silicas as anticaking agents in vitamin preparations (limited to 5%), and 25-hydroxyvitamin D3 as a vitamin D3 source in broiler chicken feed and water (not exceeding 69 ppb in feed or 34.5 ppb in water), each with defined purity and usage specifications.
Intentional Genomic Alterations in Animals
21 CFR Part 528 establishes regulatory pathways for intentional genomic alterations in animals, including rabbits producing recombinant human Factor VII in milk for hemophilia treatment, genetically modified Atlantic salmon with enhanced growth rates in contained freshwater facilities, pigs with CD163 gene deletion conferring PRRSV resistance, pigs with modified GGTA1 gene for use as food or therapeutic sources, and chickens producing human lysosomal acid lipase for medical treatment. Food and feed restrictions apply to certain lineages.
Ear, Nose, and Throat Devices
21 CFR Part 874 establishes FDA classification and regulatory requirements for ear, nose, and throat (ENT) medical devices intended for human use in commercial distribution. The regulation outlines premarket approval procedures, including requirements for Class III devices to obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercialization, with specified grace periods for devices marketed before May 28, 1976, and mandatory immediate approval for new or substantially altered devices.
Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food
21 CFR Part 579 establishes safety standards for using ionizing radiation in animal feed and pet food production. Facilities may use gamma rays (cobalt-60, cesium-137) or electrons (up to 10 MeV) to treat complete animal diets and ingredients. For poultry feed, additional X-ray sources are permitted. Minimum effective dose for salmonella control is 2.0 kGy; maximum is 25 kGy. Facilities must comply with Part 507 and incorporate applicable Part 179 food irradiation regulations.
Medical Device Classification Procedures
21 CFR Part 860 establishes the procedures and criteria for classifying and reclassifying medical devices intended for human use into one of three regulatory control classes (I, II, or III) based on safety and effectiveness. The regulation defines classification criteria, describes the roles of advisory committees and the FDA Commissioner, and prescribes the data required to support device classification determinations. It also governs public participation and information disclosure in classification proceedings.
Gastroenterology-Urology Devices
21 CFR Part 876 establishes the classification and regulatory framework for gastroenterology-urology devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, including that Class III devices require FDA approval via premarket approval application (PMA) or product development protocol (PDP) before commercial distribution, with specified grace periods for devices marketed before May 28, 1976, and mandatory approval for new devices introduced after that date.
Neurological Devices
21 CFR Part 882 establishes the FDA regulatory framework for neurological devices intended for human use in commercial distribution. The regulation sets forth device classification requirements and premarket approval procedures, specifying that class III neurological devices require FDA premarket approval (PMA) or completed product development protocol (PDP) before commercial distribution, with grace periods for devices marketed before May 28, 1976, but not for new devices introduced after that date.
In Vitro Diagnostic Products for Human Use
21 CFR Part 809 establishes regulatory requirements for in vitro diagnostic (IVD) products intended for human use, including reagents, instruments, and systems used to diagnose disease or determine health status. The regulation defines IVD products as medical devices under the Federal Food, Drug, and Cosmetic Act, specifies labeling requirements including proprietary name, intended use, ingredient declarations, warnings, and storage instructions, and addresses confidentiality of submitted data. Requirements vary by product class and may include prescription restrictions and hazard-specific precautions.
Performance Standards for Ionizing Radiation Emitting Products
21 CFR Part 1020 establishes performance standards for ionizing radiation emitted by television receivers with cathode ray tubes manufactured after January 15, 1970. The regulation limits radiation exposure rates to 0.5 milliroentgens per hour at 5 centimeters from the external surface, with measurement requirements and testing conditions specified for user controls, service controls, and component failure scenarios. Manufacturers must affix warning labels on receivers exceeding exposure limits.
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.
Notification of Defects or Failure to Comply
21 CFR Part 1003 establishes notification requirements for manufacturers of electronic products regarding defects or non-compliance with Federal standards, particularly those involving unintended or excessive electronic product radiation emissions that pose injury risk. Manufacturers must immediately notify the Secretary and relevant dealers, distributors, and purchasers upon discovery of defects or compliance failures in products manufactured after October 1968.
Ophthalmic Devices
21 CFR Part 886 establishes the FDA regulatory framework for ophthalmic devices intended for human use in commercial distribution. The regulation sets forth device classifications, premarket notification requirements under part 807, and premarket approval (PMA) procedures for class III devices. Manufacturers must demonstrate substantial equivalence to existing devices or obtain FDA approval before commercial distribution, with specific grace periods and effective dates specified for different device categories introduced before or after May 28, 1976.
Definitions
21 CFR Part 1300 establishes definitions for controlled substances under the Controlled Substances Act and related regulations. Key definitions include anabolic steroids (controlled hormonal substances chemically related to testosterone), automated dispensing systems for medication management, and basic chemical classes of controlled substances. The regulation clarifies DEA authority and distinguishes between controlled substances and dietary ingredients or botanical compounds that are exempt from classification.