Information Collection

Investigational Device Exemptions Reports and Records - 21 CFR 812

IC 5718 under ICR 201212-0910-011 · OMB 0910-0078.

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Information Collection (IC) Details

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IC Title:	Investigational Device Exemptions Reports and Records - 21 CFR 812	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 800.812.25 21 CFR 800.812.27 21 CFR 800.812.35 21 CFR 800.812.36 21 CFR 800.812.140 21 CFR 800.812.150 21 CFR 800.812.10 21 CFR 800.812.20

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: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 465	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	Previously Approved
Annual Number of Responses for this IC	7,825	7,825
Annual IC Time Burden (Hours)	48,986	48,986
Annual IC Cost Burden (Dollars)	0	0

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