Written Request for Review--810.12(a-b)

Medical Device Recall Authority

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0432 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Written Request for Review--810.12(a-b)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 810.10(d) 21 CFR 810.11(a) 21 CFR 810.12 (a-b) 21 CFR 810.14 21 CFR 810.15 (a-c) 21 CFR 810.15(d) 21 CFR 810.15 (e) 21 CFR 810.16 (a-b) 21 CFR 810.17 ( a) 21 CFR 810.15 (b)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	8	8
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.