Postmarket Surveillance of Medical Devices

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0449 can be found here:

Documents and Forms

Document Name Document Type

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Information Collection (IC) Details

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IC Title:	Postmarket Surveillance of Medical Devices	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 800.822.9 21 CFR 800.822.10 21 CFR 800.822.21 21 CFR 800.822.27 21 CFR 800.822.28 21 CFR 800.822.29 21 CFR 800.822.30 21 CFR 800.822.34 21 CFR 800.822.38

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: 73	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	Previously Approved
Annual Number of Responses for this IC	73	-65	138
Annual IC Time Burden (Hours)	4,440	593	3,847
Annual IC Cost Burden (Dollars)	0	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.