Banned Devices

United States · Last verified: 2026-09-08

Number
21 CFR 895
Type
Regulation
Issuer
U.S. FDA
Status
in_force
Authority
FDA / CDRH

What this covers

禁用器械:规定 FDA 认定并禁止某类器械的程序、企业提交资料、标签与特殊生效日期,并列出已禁清单(义发纤维、粉末外科手套、粉末检查手套、手套润滑用可吸收粉、用于自伤或攻击行为的电刺激器械)。

Official text: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-895

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

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