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Affichage de 1–50 sur 63 réglementations
Environmental Impact Considerations
21 CFR Part 25 establishes FDA procedures for implementing the National Environmental Policy Act (NEPA), requiring environmental impact assessments for major Federal actions related to FDA-regulated products including drugs, biologics, and medical devices. The regulation defines key NEPA terms and establishes supplemental procedures consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
Patent Term Restoration
This regulation establishes FDA procedures for reviewing patent term restoration applications under 35 U.S.C. 156 for patents related to drugs, medical devices, food additives, and color additives. It defines the FDA's role in determining patent eligibility, calculating regulatory review periods, and adjudicating due diligence challenges through informal hearings.
Civil Money Penalties Hearings
21 CFR Part 17 establishes procedures for FDA administrative hearings on civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Penalties apply to violations involving prescription drug marketing, medical devices, pesticide residues, clinical trials, direct-to-consumer drug advertising, biologics, electronic products, mammography standards, vaccine record falsification, and tobacco products.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
Enforcement Policy
FDA enforcement policy governing regulatory actions under the Federal Food, Drug, and Cosmetic Act. Establishes procedures for recalls, corrections, and voluntary removals of violative products including foods, drugs, devices, cosmetics, biologics, and tobacco. Defines recall classifications based on health hazard severity and clarifies distinctions between recalls, market withdrawals, and stock recoveries.
Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 58 establishes Good Laboratory Practice (GLP) standards for nonclinical laboratory studies supporting FDA applications for regulated products including drugs, medical devices, biologics, food and color additives, and electronic products. The regulation ensures quality and integrity of safety data submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act by defining requirements for test articles, control articles, study scope, and application types covered.
Product Jurisdiction
21 CFR Part 3 establishes FDA procedures for determining which internal agency component has primary jurisdiction over premarket review of combination products containing any mixture of drugs, devices, and biologics. It implements the Safe Medical Devices Act and modernization amendments to streamline oversight by eliminating the need for multiple FDA component approvals on a single product.
Institutional Review Boards
21 CFR Part 56 establishes standards for Institutional Review Boards (IRBs) that oversee clinical investigations of FDA-regulated products including drugs, medical devices, biological products, foods, dietary supplements, and electronic products. The regulation defines the composition, operation, and responsibilities of IRBs to protect the rights and welfare of human research subjects.
Financial Disclosure by Clinical Investigators
FDA regulation requiring disclosure of financial interests and compensation arrangements between clinical investigators and study sponsors for drugs and medical devices. Investigators must disclose equity interests, proprietary interests in tested products, and compensation affected by study outcomes to minimize potential bias in clinical data submitted for FDA marketing applications.
Electronic Records; Electronic Signatures
21 CFR Part 11 establishes FDA criteria for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. The regulation applies to electronic records created, modified, maintained, or transmitted under FDA regulations and those submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Electronic signatures meeting these requirements are treated as equivalent to handwritten signatures unless specifically excepted. Electronic records may replace paper records unless paper is required, and computer systems must be subject to FDA inspection.
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
21 CFR Part 99 establishes requirements for manufacturers disseminating information about unapproved or new uses of FDA-approved drugs, biologics, and devices to healthcare practitioners, pharmacy benefit managers, health insurers, group health plans, and government agencies. The regulation defines key terms including health care practitioners, manufacturers, and new uses, and specifies that unsolicited requests from healthcare providers are exempted from these dissemination requirements.
Regulation of Combination Products
21 CFR Part 4 establishes current good manufacturing practice (CGMP) requirements for combination products, which are products containing two or more constituent parts (drugs, devices, or biological products). The regulation clarifies how CGMP rules apply to both co-packaged and single-entity combination products, defines key terms, and outlines the regulatory framework for designing and implementing CGMP operating systems at manufacturing facilities.
Medication Guides for Prescription Drug Products
21 CFR Part 208 establishes FDA requirements for Medication Guides—patient labeling for prescription drug products and biologics that present serious public health concerns. Manufacturers must distribute FDA-approved patient information for drugs where patient awareness of risks, adverse effects, or adherence is critical to safe and effective use, with guidance on content, format, and distribution requirements.
Current Good Manufacturing Practice for Medical Gases
21 CFR Part 213 establishes current good manufacturing practice (cGMP) requirements for the preparation of designated medical gases for human and animal administration. The regulation defines key terms including batches, lots, components, acceptance criteria, and lot numbering requirements. It applies to manufacturers and processors involved in liquefied, nonliquefied, or cryogenic medical gas production, packaging, labeling, testing, and quality control operations.
Ophthalmic Drug Products for Over-the-Counter Human Use
This regulation (21 CFR Part 349) establishes standards for over-the-counter ophthalmic drug products for topical use on eyes and eyelids. It defines product categories including astringents, demulcents, emollients, and irrigating solutions, specifying approved active ingredients with their required concentrations. Products meeting these criteria are recognized as safe and effective and not misbranded.
Certification and Postmarketing Reporting for Designated Medical Gases
21 CFR Part 230 establishes FDA procedures for certification and postmarketing surveillance of designated medical gases. It requires applicants to submit certifications under the Federal Food, Drug, and Cosmetic Act and defines requirements for adverse event reporting, including serious adverse events. The regulation sets minimum data standards for individual case safety reports and establishes postmarketing safety monitoring systems.
Diagnostic Radiopharmaceuticals
This regulation establishes FDA standards for diagnostic radiopharmaceuticals used in vivo for diagnostic and monitoring purposes. It defines diagnostic radiopharmaceuticals, outlines safety and effectiveness evaluation criteria including pharmacological/toxicological activity and absorbed radiation dose, categorizes proposed indications (structure delineation, functional assessment, disease detection, patient management), and specifies methods for demonstrating effectiveness through clinical evaluation against reliable diagnostic standards.
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter nighttime sleep-aid drug products containing diphenhydramine hydrochloride or diphenhydramine citrate. It specifies approved active ingredients, dosage limits (50 mg and 76 mg respectively), labeling requirements including indications and warnings, and defines nighttime sleep-aids as drugs for relief of occasional sleeplessness. Products meeting these conditions are recognized as safe and effective.
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.
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.
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.
Mammography
21 CFR Part 900 implements the Mammography Quality Standards Act (MQSA) by establishing procedures for FDA-approved accreditation bodies to evaluate mammography facilities and setting minimum national quality standards. The regulation defines key terms related to mammography operations, including accreditation bodies, adverse events (poor image quality, delayed reporting, unqualified personnel), air kerma measurement, and continuing education requirements for clinical staff.
Medical Device Reporting
21 CFR Part 803 establishes medical device reporting requirements for device user facilities, manufacturers, importers, and distributors. Device user facilities must report deaths and serious injuries caused or contributed to by devices, maintain adverse event files, and submit annual summaries. Manufacturers and importers must report similar events and device malfunctions, while distributors must maintain incident records without reporting obligations. These requirements protect public health by ensuring devices remain safe, effective, and not adulterated or misbranded.
General Hospital and Personal Use Devices
21 CFR Part 880 establishes the regulatory classification and premarket approval requirements for general hospital and personal use devices intended for human use in commercial distribution. The regulation defines the scope of device classification, requires manufacturers to demonstrate substantial equivalence, and specifies that Class III devices require FDA premarket approval before commercial distribution, with grace periods for devices marketed before May 28, 1976.
Human Cells, Tissues, and Cellular and Tissue-Based Products
21 CFR Part 1271 establishes FDA requirements for establishments manufacturing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The regulation creates an electronic registration and listing system and mandates compliance with donor-eligibility procedures, current good tissue practice standards, and communicable disease prevention measures. It applies to HCT/P manufacturers regulated under the Public Health Service Act, whether or not products enter interstate commerce, and requires adherence to manufacturing and quality standards.
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.
Current Good Manufacturing Practice for Blood and Blood Components
21 CFR Part 606 establishes current good manufacturing practice (cGMP) standards for blood and blood components collection, processing, compatibility testing, storage and distribution. The regulation defines key terms including blood, blood components, plasmapheresis, plateletpheresis, and leukapheresis procedures. It requires facilities and personnel to maintain adequate safety, purity, potency and effectiveness, with personnel having appropriate education, training and experience. Facilities must be clean, orderly, suitably constructed and properly maintained to ensure compliance with cGMP requirements.
Records and Reports
21 CFR Part 1002 establishes record-keeping and reporting requirements for manufacturers, dealers, and distributors of electronic products, particularly radiation-emitting devices. Manufacturers must submit performance data, technical safety information, and test data to the FDA's Center for Devices and Radiological Health. Exemptions apply to products solely for export, components sold to other manufacturers, U.S. Government products with national security restrictions, and certain diagnostic x-ray equipment assemblers. Trade secret information is kept confidential.
General and Plastic Surgery Devices
21 CFR Part 878 establishes the FDA classification framework for general and plastic surgery devices intended for human use in commercial distribution. The regulation outlines premarket approval requirements, particularly for Class III devices, which must obtain FDA approval via premarket approval (PMA) or product development protocol (PDP) before commercial distribution unless exempt or reclassified. Manufacturers must demonstrate substantial equivalence and comply with applicable regulatory submission procedures.
Investigational Device Exemptions
21 CFR Part 812 establishes procedures for Investigational Device Exemptions (IDEs), permitting unapproved medical devices to be shipped and investigated in clinical trials while exempting them from certain FDA requirements including premarket approval, performance standards, and misbranding rules. The regulation defines IDE applicability, abbreviated requirements for non-significant-risk devices, and exemptions for certain device categories.
Additional Standards for Diagnostic Substances for Laboratory Tests
21 CFR Part 660 establishes additional standards for diagnostic substances used in laboratory tests, specifically covering antibody to hepatitis B surface antigen. The regulation defines proper sourcing from immunized animal plasma/blood or hepatitis B surface antigen-positive human donors, specifies processing methods to ensure specificity and potency, and mandates labeling requirements including source indication, test method recommendations, and hepatitis transmission warnings. Ancillary reagents must meet purity standards and be manufactured to prevent contamination.
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.
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.
Biological Products: General
21 CFR Part 600 establishes FDA submission procedures and mailing addresses for licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The regulation specifies separate submission channels for biologics license applications, deviation reports, samples, and promotional materials, with distinct addresses for each center and submission type, including special handling for radioactive biological products.
Performance Standard for Electrode Lead Wires and Patient Cables
This regulation establishes a performance standard for electrode lead wires and patient cables used with medical devices, requiring connectors with conductive patient connections to comply with IEC 601-1 subclause 56.3(c). Manufacturers must demonstrate compliance through inspection and testing by May 1998 for specified devices and May 2000 for others, with provisions for exemptions or variances upon petition.
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
21 CFR Part 807 establishes registration and device listing requirements for manufacturers and initial importers of medical devices. The regulation defines key terms including commercial distribution, establishment, manufacture, official correspondent, and initial importer. It outlines exemptions from commercial distribution requirements, including internal transfers within affiliated companies, investigational use devices, and certain pre-1976 Class III devices. Device manufacturers and importers must register establishments annually and maintain current officer/director information with the FDA.
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.
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.
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.
Hematology and Pathology Devices
21 CFR Part 864 establishes the regulatory framework for hematology and pathology devices intended for human use in commercial distribution. It outlines classification requirements, premarket approval timelines for Class III devices, and exemptions from premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act. Manufacturers must demonstrate substantial equivalence to existing devices and comply with applicable FDA guidance.
Banned Devices
21 CFR Part 895 establishes procedures for the FDA Commissioner to ban medical devices intended for human use that present substantial deception or unreasonable risk of illness or injury. A device becomes adulterated when banned and cannot be relabeled for veterinary use to circumvent the ban. The Commissioner may initiate banning proceedings based on available data when risks cannot be corrected through labeling changes.
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.
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.
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.