21 C.F.R. § 814.120 Temporary suspension of approval of an HDE.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart H—Humanitarian Use Devices
§ 814.120 Temporary suspension of approval of an HDE.