Information Collection

Medical Devices, Third Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. MRA

IC 6022 under ICR 200501-0910-001 · OMB 0910-0378.

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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. MRA	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: 15	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	210	-10	220
Annual IC Time Burden (Hours)	14,622	8,862	5,760
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.