CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > SUBPART H—Humanitarian Use Devices (§814.100 to §814.126) > 814.120—Temporary suspension of approval of an HDE.