Information Collection

Medical Devices; Reports of Corrections and Removals

IC 5979 under ICR 201404-0910-006 · OMB 0910-0359.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0359 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 806 Medical Devices; Reports of Corrections and Removals	Form and Instruction
806 Reports of Corrections and Removals of Medical Devices a eSubmitter 806 report blank screens.pdf	Form and Instruction

IC Title:

Medical Devices; Reports of Corrections and Removals

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 806.20 21 CFR 806.10

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	806	Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products	eSubmitter 806 report blank screens.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	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,033	0	277	756
Annual IC Time Burden (Hours)	14,408	5,918	930	7,560
Annual IC Cost Burden (Dollars)	30,660	30,660	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.