Information Collection

Medical Device And Laboratory Product Problem Reporting Program

IC 109712 under ICR 198412-0910-007 · OMB 0910-0143.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0143 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM	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
Form	FDA 2519F				No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,500	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,500	100	2,400
Annual IC Time Burden (Hours)	750	150	600
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.