De Novo Classification

Definitions #

An FDA pathway to classify a low- to moderate-risk medical device that has no valid predicate device, making it Class I or II instead of automatically Class III.

Technical Under FD&C Act 513(f)(2), the FDA determines whether a device without an identical or similar predicate can be reclassified as Class I or II with special controls, replacing the automatic Class III designation.

Etymology #

From Latin, 'de novo' meaning 'anew' or 'from the beginning' — indicating a fresh classification not based on an existing predicate.

Collocations #

De Novo request 企业向 FDA 提交的 de novo 分类申请
special controls 特殊控制，de novo 分类中为 Class II 设备设定的额外要求（如性能测试、指南）
predicate device 已有同类设备，作为 510(k) 对比基准；de novo 无需 predicate

Real Business Examples #

The software company pursued De Novo Classification because no legally marketed predicate existed for its AI-based diagnostic tool.
The FDA granted the De Novo request, classifying the novel wound dressing as Class II with special controls for biocompatibility testing.

Register & Variants #

Register: formal
BrE/AmE: 美式（FDA 法规术语），全球其他监管机构无此专属路径

Synonyms & Antonyms #

Synonyms: De Novo pathway, De Novo request (as a procedural term)
Antonyms: 510(k) clearance (when predicate-based)

Common Errors #

把 de novo 当作免费快速通道 de novo 申请仍需提交完整临床和科学证据，FDA 审核时间可能较长，且需支付 MDUFA 费用
误以为 de novo 属于 Class III 审批 de novo 的目的恰恰是将设备分类为 Class I/II，避免 Class III 的 PMA 要求

Confusable Terms #

510(k) vs De Novo Classification: 510(k) 基于 predicate 证明实质性等同，de novo 则用于无 predicate 的设备分类

Frequently Asked Questions

de novo 和 510(k) 的主要区别是什么？?

510(k) 需要与现有 predicate 对比，证明等效；de novo 适用于无 predicate 的创新设备，由 FDA 自行评估风险

de novo 分类后是否还需要上市前批准？?

若归类为 Class II，通常只需遵守特殊控制即可上市；若归类为 Class I，一般无需提交申请（除非被豁免）

Published: 2026-09-24 Category: Regulatory