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: Established three regulatory classes for medical devices based on their risks and the controls necessary to provide reasonable assurance of safety and effectiveness
Safe Medical Devices Act of 1990: Strengthened FDA's post-market surveillance capabilities and established requirements for adverse event reporting
21 CFR Part 820: Quality System Regulation (QSR) that establishes quality management system requirements for medical devices
HIPAA: Health Insurance Portability and Accountability Act - Governs the protection and handling of protected health information
Patent Act: Federal law governing patents and intellectual property protection for medical device innovations
ISO 13485: International standard for medical devices quality management systems requirements
ISO 14971: International standard for application of risk management to medical devices
FDA Classification System: Regulatory framework categorizing medical devices into Class I, II, or III based on their risk level and regulatory controls needed
510(k) Requirements: Premarket notification process required for most Class II devices to demonstrate substantial equivalence to a legally marketed device
PMA Requirements: Premarket Approval process required for Class III devices, involving scientific review to ensure safety and effectiveness
Medical Device Reporting (MDR): FDA's adverse event reporting system requiring manufacturers to report device-related deaths, serious injuries, and malfunctions
Uniform Commercial Code (UCC): State-adopted uniform law governing commercial transactions, including sales and licensing of goods
Export Administration Regulations (EAR): Federal regulations governing the export of commercial and dual-use medical devices
Anti-kickback Regulations: Federal laws prohibiting the exchange of anything of value to induce or reward referrals of federal healthcare program business
