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HHS/FDA | RIN: 0910-AG29 | Publication ID: Spring 2013 |
Title: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure | |
Abstract: The regulation would amend 21 CFR 814 to require applicants who submit premarket approval applications or a supplement to an application, product development protocols, and applications for humanitarian device exemptions to include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected patients. This rule would not require additional clinical research and simply requires the applicant to briefly summarize readily available information. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 814 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 360e 21 USC 360e-1 21 USC 360j 21 USC 371 |
Legal Deadline:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Paul Gadiock Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432, Silver Spring, MD 20993-0002 Phone:301 796-5736 Fax:301 847-8145 Email: paul.gadiock@fda.hhs.gov |