Information Collection

510(k) Third-Party Review Program

IC 6015 under ICR 202504-0910-003 · OMB 0910-0375.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0910-0375_Guidance; 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergen	Other-Guidance; 510(k) Third Party R
0910-0375_Guidance; 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergen	Other-Guidance; 510(k) Third Party R

IC Title:

Agency IC Tracking Number:

CDRH

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; 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review				https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program-and-third-party-emergency-use-authorization-eua-review	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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	275	0	275
Annual IC Time Burden (Hours)	6,439	15	6,424
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.

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