Information Collection

Medical Devices; Medical Device Reporting;manufacturer reportiing importer reporting, user facility reporting, distributor reporting

IC 6114 under ICR 200001-0910-003 · OMB 0910-0437.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0437 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

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IC Title:

Medical Devices; Medical Device Reporting;manufacturer reportiing importer reporting, user facility reporting, distributor reporting

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
Form	FDA-3417				No	No
Form	FDA-3419				No	No

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 39,764

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	39,764	39,764
Annual IC Time Burden (Hours)	91,306	91,306
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded

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

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