Information Collection

Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)

IC 230334 under ICR 201803-0910-002 · OMB 0910-0852.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Agency Guidance.docx	Other-Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

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			Agency Guidance.docx		Yes	No	Printable Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 4,080

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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4,080	4,080
Annual IC Time Burden (Hours)	1,020	1,020
Annual IC Cost Burden (Dollars)	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.