# 21 C.F.R. § 814.112 (2026): Filing an HDE

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P814_S814_112

## Section

- **Citation:** 21 C.F.R. § 814.112 (2026)
- **Heading:** Filing an HDE
- **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 / § 814.112: § 814.112   Filing an HDE.

## Text

(a) The filing of an HDE means that FDA has made a threshold determination that the application is sufficiently complete to permit substantive review. Within 30 days from the date an HDE is received by FDA, the agency will notify the applicant whether the application has been filed. FDA may refuse to file an HDE if any of the following applies:
(1) The application is incomplete because it does not on its face contain all the information required under § 814.104(b);
(2) FDA determines that there is a comparable device available (other than another HUD approved under this subpart or a device under an approved IDE) to treat or diagnose the disease or condition for which approval of the HUD is being sought; or
(3) The application contains an untrue statement of material fact or omits material information.
(4) The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by part 54 of this chapter.
(b) The provisions contained in § 814.42(b), (c), and (d) regarding notification of filing decisions, filing dates, the start of the 75-day review period, and applicant's options in response to FDA refuse to file decisions shall apply to HDE's.
[61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 FR 59221, 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_112. Check the current official text before relying on it. Not legal advice.