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Federal Food, Drug, and Cosmetic Act (FDCA): Primary federal law governing medical devices in the US, establishing the basic framework for medical device regulation

Medical Device Amendments of 1976: Key amendment to FDCA that established the three-class system for medical device regulation and controls

Safe Medical Devices Act of 1990: Legislation requiring device user facilities to report incidents to FDA and manufacturers

21 CFR Part 820: Quality System Regulation (QSR) establishing current good manufacturing practice requirements for medical devices

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

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

Uniform Commercial Code (UCC): State-adopted uniform law governing commercial transactions, including sales and warranties

FDA Quality System Regulation: Requirements for establishing and maintaining quality management systems for medical devices

Product Liability Laws: State and federal laws governing manufacturer liability for defective medical devices

Environmental Protection Agency Requirements: Regulations governing environmental impact and disposal of medical devices

HIPAA Security Rule: Specific requirements for protecting electronic personal health information

Export Administration Regulations: Federal regulations controlling the export and import of medical devices

DOT Regulations: Department of Transportation requirements for shipping and handling medical devices

Premarket Notification (510(k)): FDA requirement for demonstrating substantial equivalence to a legally marketed device

Premarket Approval (PMA): FDA's strictest device review process for Class III devices