Information Collection

Device corrections and removals

IC 5979 under ICR 202309-0910-003 · OMB 0910-0359.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form e-Form/Link Device corrections and removals	Form and Instruction
e-Form/Link Device Correction/Removal Report 0359Device Correction-Removal Report for Industry ver 02-22-23.pdf	Form and Instruction
e-Form/Link Device Correction/Removal Report 0359Device Correction-Removal Report for Industry ver 02-22-23 (002)--CDRH to APRA 10-12-23.pdf	Form and Instruction

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 806

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
Form and Instruction	e-Form/Link	Device Correction/Removal Report	0359Device Correction-Removal Report for Industry ver 02-22-23 (002)--CDRH to APRA 10-12-23.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1,033

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	1,033	1,033
Annual IC Time Burden (Hours)	11,260	11,260
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.