IDE Reporting (including reports for nonsignificant studies)

Investigational Device Exemptions

Documents and Forms

Document Name Document Type
GFI Consent IVD human specimens April 2006.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	IDE Reporting (including reports for nonsignificant studies)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 812 21 CFR 812.150

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI Consent IVD human specimens April 2006.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: 1,200	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	Previously Approved
Annual Number of Responses for this IC	5,513	-2,461	7,974
Annual IC Time Burden (Hours)	53,897	6	53,891
Annual IC Cost Burden (Dollars)	0	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.