Specific Labeling for Certain Devices - Natural Rubber Latex Condoms

Medical Device Labeling Requirements

Documents and Forms

Document Name Document Type
Guidance_Labeling for Natural Rubber Latex Condom.pdf www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/labeling-natural-rubber-l Other-Guidance

Information Collection (IC) Details

IC Title:	Specific Labeling for Certain Devices - Natural Rubber Latex Condoms	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 884

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Guidance_Labeling for Natural Rubber Latex Condom.pdf	https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/labeling-natural-rubber-latex-condoms-classified-under-21-cfr-8845300-class-ii-special-controls	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	60	60
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.