De Novo request under 21 U.S.C. 513(f)(2)(ii)

Medical Device De Novo Classification Process

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0844 can be found here:

Documents and Forms

Document Name Document Type
NEW_Guidance_8-2017.docx Other-Guidance:De Novo Classificatio

Information Collection (IC) Details

IC Title:	De Novo request under 21 U.S.C. 513(f)(2)(ii)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

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
Other-Guidance:De Novo Classification Process (Evaluation of Automatic Class III Designation)			NEW_Guidance_8-2017.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 26	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-26	26
Annual IC Time Burden (Hours)	-4,680	4,680
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.