GroundRules
21 CFR 814.120: Temporary suspension of approval of an HDE.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
- Subpart H—Humanitarian Use Devices
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON