Information Collection

Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records

IC 192723 under ICR 201608-0910-014 · OMB 0910-0449.

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Documents and Forms

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IC Title:

Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 800.822.31 21 CFR 800.822.32

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 84

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	524	524
Annual IC Time Burden (Hours)	4,585	4,585
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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Title	Document	Date Uploaded
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.