Pediatric uses outside approved indication

Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

Documents and Forms

Document Name Document Type
Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf Other-Agency Guidance Document
eCopy Guidance.pdf Other-Agency Guidance Document

Information Collection (IC) Details

IC Title:	Pediatric uses outside approved indication	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document			Providing-Information-about-Pediatric-Uses-of-Medical-Devices---Guidance-for-Industry-and-FDA-Staff.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance Document			eCopy Guidance.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 800	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	800	800
Annual IC Time Burden (Hours)	400	400
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.