21 CFR 814.108 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Premarket Approval Of Medical Devices (§ 814.1 To § 814.126) — Humanitarian Use Devices (§ 814.100 To § 814.126) — Supplemental applications.

4 Aug 2016

After FDA approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMA's under § 814.39, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 814.110. The timeframes for review of, and FDA action on, an HDE supplement are the same as those provided in § 814.114 for an HDE.

21 CFR 814.108

[63 FR 59220, Nov. 3, 1998]