Information Collection

Premarket Approval of Medical Devices Reporting Requirements

IC 5826 under ICR 202001-0910-010 · OMB 0910-0231.

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Information Collection (IC) Details

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IC Title:	Premarket Approval of Medical Devices Reporting Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814.15 21 CFR 814.20 21 CFR 814.37 21 CFR 814.39 21 CFR 814.82 21 CFR 814.84

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: 5,096	Number of Respondents for Small Entity: 500

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,096	250	4,846
Annual IC Time Burden (Hours)	384,936	34,374	350,562
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.