Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.

Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0661 can be found here:

Documents and Forms

Document Name Document Type
Guidance - HDE-Questions and Answers.doc Other-Guidance - Questions and Answe

Information Collection (IC) Details

IC Title:	Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance - Questions and Answers			Guidance - HDE-Questions and Answers.doc		Yes	No	Printable Only

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 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	500	500
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.