Information Collection

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

IC 6135 under ICR 201309-0910-003 · OMB 0910-0449.

⚠️ Notice: This information collection may be referencing outdated material.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

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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 800.822.38 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

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: 374	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	636	563	73
Annual IC Time Burden (Hours)	33,360	28,920	4,440
Annual IC Cost Burden (Dollars)	0	0	0

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