21 CFR § 814.120 Premarket Approval of Medical Devices

§ 814.120 Temporary suspension of approval of an HDE.

Current through Sep 8, 2026 · Read all of Part 814

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]

← § 814.118 Denial of approval or withdrawal of approval of an HDE.§ 814.122 Confidentiality of data and information. →