21 CFR § 814.120 - Temporary suspension of approval of an HDE.

---
identifier: "/us/cfr/t21/s814.120"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 814.120 - Temporary suspension of approval of an HDE."
title_number: 21
title_name: "Food and Drugs"
section_number: "814.120"
section_name: "Temporary suspension of approval of an HDE."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "814"
part_name: "PREMARKET APPROVAL OF MEDICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381."
regulatory_source: "51 FR 26364, July 22, 1986, unless otherwise noted."
cfr_part: "814"
---


# 814.120 Temporary suspension of approval of an HDE.

An HDE or HDE supplement may be temporarily suspended for the same reasons and in the same manner as prescribed for PMA's in § 814.47.

[63 FR 59221, Nov. 3, 1998]