Humanitarian Device Exemption Applications (HDE) - Requirement to Include Readily Available Information Concerning Actual and Potential Uses of the Device

Companion Proposed Rule: Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0748 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Humanitarian Device Exemption Applications (HDE) - Requirement to Include Readily Available Information Concerning Actual and Potential Uses of the Device	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814.104(b)(6)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to New Statute
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	20	20
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.