Premarket Approval of Medical Devices

United States · Last verified: 2026-09-08

Number

21 CFR 814

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

PMA 上市前批准：III 类器械 PMA 申请的内容与格式、FDA 审评与决定、批准后要求（含 PMA 补充）；Subpart H 为人道主义用途器械 HDE。

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