Information Collection

Investigational Device Exemption Reports And Records -- 21 Cfr 812

IC 109584 under ICR 199303-0910-002 · OMB 0910-0078.

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IC Title:

INVESTIGATIONAL DEVICE EXEMPTION REPORTS AND RECORDS -- 21 CFR 812

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 700

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4,174	4,174
Annual IC Time Burden (Hours)	53,670	53,670
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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Title	Document	Date Uploaded

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