Environmental Impact Considerations

United States · Last verified: 2026-09-08

Number

21 CFR 25

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

环境影响考量：FDA 行动的环境评价（EA）与环境影响报告（EIS）要求，以及分类豁免（categorical exclusion）情形——多数器械上市前申请可依此主张豁免。

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