Information Collection

Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting

IC 6116 under ICR 200909-0910-006 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Form 3419 Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting	Form and Instruction
MedWatch HL7 e- Version.xls	Instruction
3419 Medical Device Reporting Annual User Facility Report Form FDA 3419.pdf	Form and Instruction
FDA 3500A Medical device Adverse Event Report eMDR eSubmitter Screenshots.doc	Form and Instruction
eMDR draft guidance.doc eMDR draft guidance	IC Document

IC Title:

Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 803.20 21 CFR 803.19 21 CFR 803.30 21 CFR 803.32 21 CFR 803.33 21 CFR 803.40 21 CFR 803.42

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3419	Medical Device Reporting Annual User Facility Report	Form FDA 3419.pdf	Yes	Yes	Fillable Printable
Form and Instruction	FDA 3500A	Medical device Adverse Event Report	eMDR eSubmitter Screenshots.doc	Yes	Yes	Fillable Printable
Instruction			MedWatch HL7 e- Version.xls	Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 18,142

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	135,565	-108,972	244,537
Annual IC Time Burden (Hours)	21,525	-272,669	294,194
Annual IC Cost Burden (Dollars)	23,100,000	23,100,000	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
eMDR draft guidance	eMDR draft guidance.doc	09/05/2009

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