Information Collection

Reclassification Petitions for Medical Devices

IC 5757 under ICR 201806-0910-010 · OMB 0910-0138.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0138 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3429 Reclassification Petitions for Medical Devices	Form and Instruction
3429 FDA Form 3429 Form 3429.pdf	Form and Instruction
3427 FDA Form 3427 Form 3427.pdf	Form and Instruction

IC Title:

Reclassification Petitions for Medical Devices

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 860.123

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 and Instruction	3429	FDA Form 3429	Form 3429.pdf		Yes	Yes	Fillable Printable
Form and Instruction	3427	FDA Form 3427	Form 3427.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 6

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	Previously Approved
Annual Number of Responses for this IC	6	6
Annual IC Time Burden (Hours)	3,000	3,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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