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.
[63 FR 59221, Nov. 3, 1998]
Page Last Updated: 06/01/2013
Note: If you need help accessing information in different file formats, see
Instructions for Downloading Viewers and Players.