Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. Mutual Recognition Agreement

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Documents and Forms

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Information Collection (IC) Details

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IC Title:	Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. Mutual Recognition Agreement	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Voluntary

CFR Citation:

Information Collection 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: 11	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	220	8	212
Annual IC Time Burden (Hours)	5,760	-3,728	9,488
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded

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