Information Collection

Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports

IC 6135 under ICR 202505-0910-005 · OMB 0910-0449.

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Information Collection (IC) Details

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IC Title:	Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 822

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: 49	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	119	53	66
Annual IC Time Burden (Hours)	4,968	1,960	3,008
Annual IC Cost Burden (Dollars)	0	0	0

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