Medical Device Regulation in United States
The U.S. FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act. The Center for Devices and Radiological Health (CDRH) oversees pre-market review and post-market surveillance using a risk-based three-class system. The FDA is one of the most influential regulatory bodies globally.
Recent Regulatory Updates
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Minor technical update, no actual content modified
New standardized AER terminology with codes.
Sources Tracked by Qalico
Qalico continuously monitors 832 references across guidelines, regulations, and standards for United States.
Regulations
Guidelines
Device Classification
Class I (low risk, general controls only): e.g., bandages, tongue depressors — most are exempt from 510(k). Class II (moderate risk, special controls): e.g., infusion pumps, powered wheelchairs — typically requires 510(k). Class III (high risk, life-supporting): e.g., pacemakers, heart valves — requires Premarket Approval (PMA).
Official classification guidance →Official Guidance Documents
Complete FDA guidance library covering 510(k), PMA, De Novo, QSR, clinical studies, and labeling.
Requirements and guidance for the most common premarket pathway.
Updated QSR aligned with ISO 13485:2016, effective February 2026.
Standards & Key Principles
Applicable Standards
Key Principles
- Risk-based classification determines the premarket pathway
- Substantial equivalence (510k) or safety & effectiveness (PMA)
- Quality Management System aligned with ISO 13485
- Unique Device Identification (UDI) in GUDID database
- IMDRF and GHTF harmonization principles
- Clinical evidence proportional to device risk
Pre-Market Requirements
Required for most Class II devices. Demonstrates substantial equivalence to a legally marketed predicate device. FDA review target: 90 days.
Required for Class III devices. Full scientific review of safety and effectiveness with clinical data. Review target: 180 days.
For novel low-to-moderate risk devices without a predicate. Establishes a new device type with special controls. Can become a predicate for future 510(k)s.
Most Class I devices are exempt from premarket notification but must comply with general controls: labeling, establishment registration, device listing, and GMP.
Post-Market Requirements
Manufacturers must report device-related deaths and serious injuries within 30 days (5 days for urgent situations).
Devices must carry a UDI label and be registered in the GUDID database for traceability.
Systematic ongoing collection of post-market data. Class III and some Class II require Post-Market Surveillance Reports.
Ongoing compliance with QMSR including corrective and preventive actions, complaint handling, and design controls.
International Recognition & Reliance
Health Canada accepts FDA-cleared/approved data to support Medical Device Licence applications.
TGA accepts FDA marketing authorization as supporting evidence under the MDSAP framework.
PMDA references FDA decisions as supporting data for some Class II–III devices.