Medical Device Tracking Requirements

United States · Last verified: 2026-09-08

Number

21 CFR 821

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

器械追踪要求：FDA 可要求特定器械（多为植入类和生命支持类）建立追踪体系，规定制造商、分销商的追踪义务、记录内容与检查。

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