510(k) Third-Party Review Program

Documents and Forms

Document Name Document Type
Guidance Final-510(k) Review Program-2020 (002).pdf Other-Guidance for Industry, Food an
Guidance Final-510(k) Review Program-2020 (002).pdf Other-Guidance for Industry, Food an

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	510(k) Third-Party Review Program	Agency IC Tracking Number:	CDRH

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations			Guidance Final-510(k) Review Program-2020 (002).pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 41	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	275	128	147
Annual IC Time Burden (Hours)	6,424	-1,020	7,444
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.