FDA
美國食品藥物管理局
United States
Last reviewed 2026-08-05
FDA是美國醫療器材的主要監管機構。其器械與放射健康中心（CDRH）負責上市前審查、上市後監管和執法。FDA每年處理約4,000份510(k)申請和50份PMA申請，是全球最活躍的器材監管機構。
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.
器材分類
Class I, II, III
審批路徑
510(k), PMA, De Novo, HDE
核心監管職能
- ▸510(k)許可和PMA審批
- ▸MAUDE不良事件資料庫
- ▸FDA執法報告和召回
- ▸De Novo分類
- ▸突破性器材認定
§ RELATED INTELLIGENCE
- FDA MAUDE資料庫指南：搜尋不良事件報告（2026） →
- FDA AEMS 解析：取代 MAUDE 的不良事件系統（2026） →
- FDA QMSR 2026：ISO 13485 對齊、檢查方式與變更重點 →
- FDA 510(k)許可指南：等同器材、申報路徑與審查時間線（2026） →
- FDA醫療器材召回資料庫：監控I/II/III類召回（2026） →
- FDA醫療器材召回分類詳解：I類、II類與III類（2026年完整指南） →
- FDA vs EMA：醫療器材審批完整對比（2026） →
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.
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