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 .
21 CFR Part 814 · Premarket Approval of Medical Devices
§ 814.120 Temporary suspension of approval of an HDE
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Amendment history
Federal Register documents that created or amended this section.
- 63 FR 59221 3 Nov 1998