# Medical Devices; Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Withdrawal
> **Food and Drug Administration** · Direct final rule; withdrawal. · Published 2010-07-20 · 75 FR 41986
## Document
- **Document number:** 2010-17617
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 75 FR 41986
- **CFR reference:** 21 CFR 814
- **Publication date:** 2010-07-20
- **HHS docket:** Docket No. FDA-2009-N-0458
## Abstract

The Food and Drug Administration (FDA) published in the Federal Register of April 1, 2010, a direct final rule that was intended to make noncontroversial amendments to existing regulations which would require the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2010/07/20/2010-17617/medical-devices-pediatric-uses-of-devices-requirements-for-submission-of-information-on-pediatric)
---
*AI Analytics · CC0 1.0*