FDA
U.S. Food and Drug Administration
United States
Last reviewed 2026-08-05
The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enforcement. The FDA processes approximately 4,000 510(k) submissions and 50 PMA applications annually, making it the most active device regulatory body globally.
HOW FDA MEDICAL DEVICE REGULATION WORKS
CDRH oversees medical devices and radiation-emitting products. Devices are classified by risk into Classes I–III, which drives the premarket path: many Class I exemptions, 510(k) substantial equivalence for most Class II, and PMA for high-risk Class III. Novel devices without a predicate may use De Novo. Post-market, manufacturers face QSR/QMSR expectations, MDR reporting (21 CFR 803), recalls, and public surveillance databases historically centered on MAUDE with transition toward AEMS.
WHAT RA TEAMS MONITOR DAY TO DAY
Practical surveillance includes new guidance and product-code decisions, 510(k)/PMA clearances for competitors, Class I/II/III recalls, warning letters, and adverse-event patterns by product code. Manual checking across FDA pages is slow; teams typically combine openFDA pulls with automated alert systems. MedFlux aggregates FDA signals with other global regulators so US-focused teams still catch EU/China/Japan spillover risks.
DEVICE CLASSES
Class I, II, III
APPROVAL PATHWAY
510(k), PMA, De Novo, HDE
KEY REGULATORY FUNCTIONS
- ▸510(k) clearance and PMA approval
- ▸MAUDE adverse event database
- ▸FDA Enforcement Reports and recalls
- ▸De Novo classification
- ▸Breakthrough Device Designation
OFFICIAL WEBSITE
https://www.fda.gov →§ RELATED INTELLIGENCE
- FDA MAUDE Database Search (2026 AEMS Guide & openFDA API Code) →
- FDA AEMS Guide (2026): MAUDE Replacement & Adverse Event Search →
- FDA QMSR 2026: ISO 13485 Alignment, Inspections & What Changed →
- FDA 510(k) Clearance Guide: Predicate Devices, Pathways & Timelines (2026) →
- FDA Medical Device Recall Database: Monitor Class I, II & III Recalls (2026) →
- FDA Medical Device Recall Classes: Class I, II & III Explained (2026) →
- FDA vs EMA: Medical Device Approval — Complete 2026 Comparison →
Free tools: FDA recall lookup · 510(k) predicate finder
§ FAQ
What is the FDA MAUDE database?
MAUDE (Manufacturer and User Facility Device Experience) is the FDA's publicly searchable database of medical device adverse event reports. It contains millions of records from manufacturers, healthcare facilities, and voluntary reporters submitted under 21 CFR Part 803. MAUDE is transitioning to the new AEMS (Adverse Event Monitoring System) in 2026.
What is the difference between FDA 510(k) clearance and PMA approval?
A 510(k) is a premarket notification demonstrating substantial equivalence to an existing (predicate) device — it applies to most Class II devices and takes 3–6 months. PMA (Premarket Approval) is the most rigorous pathway, required for Class III devices, involving clinical data review and typically taking 1–2 years. De Novo is a third pathway for novel low-to-moderate risk devices without a predicate.
How does FDA classify medical devices?
The FDA classifies medical devices into three classes based on risk. Class I (lowest risk, e.g. bandages) — most are exempt from premarket review. Class II (moderate risk, e.g. powered wheelchairs) — typically cleared via 510(k). Class III (highest risk, e.g. heart valves) — require PMA approval. Each device is assigned a product code that determines its classification and regulatory requirements.
How do I search FDA medical device recalls?
FDA medical device recalls are published in the weekly FDA Enforcement Reports and searchable through the openFDA API. Recalls are classified as Class I (most serious — reasonable probability of serious adverse health consequences or death), Class II (may cause temporary or reversible health consequences), or Class III (unlikely to cause adverse health consequences). MedFlux monitors these recalls in real time across all device categories.
What is FDA AEMS?
AEMS (Adverse Event Monitoring System) is the FDA's new unified safety surveillance platform launched in March 2026. It replaces seven legacy databases — including MAUDE (devices), FAERS (drugs), and VAERS (vaccines) — into a single system with a unified data model and API. The transition consolidates approximately $37 million per year in operating costs and enables cross-product safety signal detection.
MedFlux monitors FDA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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