# 21 C.F.R. § 814.106 (2026): HDE amendments and resubmitted HDE's

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_106

## Section

- **Citation:** 21 C.F.R. § 814.106 (2026)
- **Heading:** HDE amendments and resubmitted HDE's
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 814: PREMARKET APPROVAL OF MEDICAL DEVICES / Subpart H: Humanitarian Use Devices / § 814.106: § 814.106   HDE amendments and resubmitted HDE's.

## Text

An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of FDA, for the same reasons and in the same manner as prescribed for PMA's in § 814.37, except that the timeframes set forth in § 814.37(c)(1) and (d) do not apply. If FDA requests an HDE applicant to submit an HDE amendment, and a written response to FDA's request is not received within 75 days of the date of the request, FDA will consider the pending HDE or HDE supplement to be withdrawn voluntarily by the applicant. Furthermore, if the HDE applicant, on its own initiative or at FDA's request, submits a major amendment as described in § 814.37(c)(1), the review period may be extended up to 75 days.
[63 FR 59220, Nov. 3, 1998]

## Nearby sections

- [21 C.F.R. § 814.100 (2026) § 814.100   Purpose and scope.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_100.md)
- [21 C.F.R. § 814.102 (2026) § 814.102   Designation of HUD status.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_102.md)
- [21 C.F.R. § 814.104 (2026) § 814.104   Original applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_104.md)
- [21 C.F.R. § 814.106 (2026) § 814.106   HDE amendments and resubmitted HDE's.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_106.md)
- [21 C.F.R. § 814.108 (2026) § 814.108   Supplemental applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_108.md)
- [21 C.F.R. § 814.110 (2026) § 814.110   New indications for use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_110.md)
- [21 C.F.R. § 814.112 (2026) § 814.112   Filing an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_112.md)
- [21 C.F.R. § 814.114 (2026) § 814.114   Timeframes for reviewing an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_114.md)
- [21 C.F.R. § 814.116 (2026) § 814.116   Procedures for review of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_116.md)
- [21 C.F.R. § 814.118 (2026) § 814.118   Denial of approval or withdrawal of approval of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_118.md)
- [21 C.F.R. § 814.120 (2026) § 814.120   Temporary suspension of approval of an HDE.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_120.md)
- [21 C.F.R. § 814.122 (2026) § 814.122   Confidentiality of data and information.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_122.md)
- [21 C.F.R. § 814.124 (2026) § 814.124   Institutional Review Board requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_124.md)
- [21 C.F.R. § 814.126 (2026) § 814.126   Postapproval requirements and reports.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_126.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_106. Check the current official text before relying on it. Not legal advice.