Federal Food, Drug, and Cosmetic Act (FDCA): Primary federal law governing food, drugs, cosmetics, and medical devices in the United States. Forms the foundation for FDA regulation of these products.
21 CFR Part 820: Quality System Regulation (QSR) that establishes quality management system requirements for medical devices manufacturers.
21 CFR Part 210/211: Current Good Manufacturing Practice (cGMP) regulations for pharmaceutical products, establishing minimum requirements for methods, facilities, and controls.
21 CFR Part 117: Preventive Controls for Human Food regulation, establishing food safety requirements for facilities that manufacture, process, pack, or hold human food.
Uniform Commercial Code (UCC): Standardized set of business laws regulating commercial transactions, including sales contracts and purchase agreements.
OSHA Regulations: Workplace safety and health regulations that must be considered in manufacturing and quality control processes.
ISO 9001: International standard for Quality Management Systems, providing framework for quality assurance and continuous improvement.
ISO 13485: Medical devices quality management system standard, specifically designed for medical device manufacturers and related service providers.
HIPAA: Health Insurance Portability and Accountability Act, governing the protection of sensitive patient health information if healthcare-related products are involved.
FDA FSMA: Food Safety Modernization Act requirements for preventive controls and food safety measures in food manufacturing and processing.
State Manufacturing Regulations: Various state-specific requirements governing manufacturing operations, licensing, and quality control within individual states.
Environmental Protection Agency (EPA) Requirements: Federal environmental regulations affecting manufacturing processes, waste disposal, and environmental impact of operations.
ICH Guidelines: International Conference on Harmonisation guidelines providing global standards for pharmaceutical quality and safety.
State Data Privacy Laws: State-specific regulations governing the collection, storage, and protection of sensitive data in business operations.
