1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
  6. Subpart H - Humanitarian Use Devices
  7. 21 CFR § 814.120
21 CFR § 814.120
Temporary suspension of approval of an HDE
June 25, 2020
CFR

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]

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§ 814.118 Denial of approval or withdrawal of approval of an HDE
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§ 814.100 Purpose and scope

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