Procedures for Performance Standards Development

United States · Last verified: 2026-09-08

Number
21 CFR 861
Type
Regulation
Issuer
U.S. FDA
Status
in_force
Authority
FDA / CDRH

What this covers

性能标准制定程序:FDA 依 FD&C 法 514 条制定、修订或撤销强制性性能标准的政策、标准内容要求、制定流程、生效日期与标准咨询委员会。

Official text: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-861

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

Facts only; not legal advice. The official current text prevails.