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Federal Food, Drug, and Cosmetic Act (FD&C Act): Primary federal law governing medical devices in the US, establishing regulatory framework for safety and effectiveness

Medical Device Amendments of 1976: Key amendment to FD&C Act establishing three regulatory classes for medical devices based on risk levels

Safe Medical Devices Act of 1990: Strengthens FDA's post-market surveillance capabilities and establishes adverse event reporting requirements

21 CFR Part 820: Quality System Regulation (QSR) establishing requirements for manufacturers' quality management systems

HIPAA: Health Insurance Portability and Accountability Act governing privacy and security of medical information

Anti-Kickback Statute: Federal law prohibiting exchange of anything of value to induce or reward referrals of federal healthcare program business

Uniform Commercial Code (UCC): Standardized set of laws governing commercial transactions, including sales and warranties

ISO 13485: International standard for quality management systems in medical device manufacturing

Medical Device Reporting (MDR): FDA regulation requiring reporting of adverse events and product problems involving medical devices

Unique Device Identification (UDI): FDA system to adequately identify medical devices through distribution and use

Good Manufacturing Practice (GMP): Quality standards ensuring consistent production and control of medical devices

State Privacy Laws: Various state-specific regulations governing data privacy and security requirements

Environmental Protection Standards: Regulations governing environmental impact, waste disposal, and packaging requirements for medical devices

Product Liability Laws: Legal framework determining manufacturer liability for defective medical devices

Export/Import Regulations: Federal requirements governing international trade of medical devices, including FDA export certificates