Information Collection

CDRH 513(g) Requests

IC 197892 under ICR 201501-0910-006 · OMB 0910-0705.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0705 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
guidance 513(g) Requests.pdf www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm	Other-513g Guidance Document

IC Title:

CDRH 513(g) Requests

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

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
Other-513g Guidance Document			guidance 513(g) Requests.pdf	http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm	Yes	No	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 114

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: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	114	114
Annual IC Time Burden (Hours)	1,368	1,368
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.