Medical Device Classification Procedures

United States · Last verified: 2026-09-08

Number

21 CFR 860

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

器械分类程序：分类依据与安全有效性判定、上市前修正案器械分类、重分类申请（513(e)/513(f)(3)）程序，以及 De Novo 从头分类请求的格式、内容与审评。

Source: U.S. Food and Drug Administration (public domain)