Information Collection

510(k) Third-Party Review Program

IC 6015 under ICR 201909-0910-004 · OMB 0910-0375.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0375 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0375_Guidance.docx	Other-Guidance for Industry, Food an

IC Title:

510(k) Third-Party Review Program

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of 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			0375_Guidance.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 7

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	147	-113	260
Annual IC Time Burden (Hours)	7,444	-5,580	13,024
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.