Information Collection

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)

IC 214356 under ICR 201801-0910-004 · OMB 0910-0616.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0616 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3674 New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)	Form
FINAL GUIDANCE 0616 12-19-14.pdf	Other-Guidance
FDA 3674 Certification of Compliance FORM FDA 3674 12-19-14.pdf	Form

IC Title:

New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data)

Agency IC Tracking Number:

CBER

Is this a Common Form? No

IC Status: Removed

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 3674	Certification of Compliance	FORM FDA 3674 12-19-14.pdf		Yes	Yes	Fillable Fileable Signable
Other-Guidance			FINAL GUIDANCE 0616 12-19-14.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 530

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 70 %

table that charts list of burden
	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-530	530
Annual IC Time Burden (Hours)	-398	398
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.