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
