Information Collection

Premarket Approval of Medical Devices - 21 CFR Part 814

IC 5826 under ICR 201409-0910-013 · OMB 0910-0231.

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Information Collection (IC) Details

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IC Title:	Premarket Approval of Medical Devices - 21 CFR Part 814	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 814.84 21 CFR 814.37 21 CFR 814.39 21 CFR 814.82

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: 2,084	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	2,084	34	2,050
Annual IC Time Burden (Hours)	123,248	22,378	100,870
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.