Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0582 can be found here:

Documents and Forms

Document Name Document Type
Guidance Informed Consent for IVD.pdf www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm Other-Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 812.2

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Guidance Informed Consent for IVD.pdf	http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 700	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Previously Approved
Annual Number of Responses for this IC	700	700
Annual IC Time Burden (Hours)	2,800	2,800
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.