Medical Device Labeling Regulations; Third-Party Disclosure

Medical Device Labeling Regulations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0485 can be found here:

Documents and Forms

Document Name Document Type
0577 Prominent-and-Conspicuous-Mark-of-Manufacturers-on-Single-Use-Devices GFI.pdf www.fda.gov/media/71187/download Other-Agency Guidance
0577 Prominent-and-Conspicuous-Mark-of-Manufacturers-on-Single-Use-Devices GFI.pdf www.fda.gov/media/71187/download Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Medical Device Labeling Regulations; Third-Party Disclosure	Agency IC Tracking Number:	CDRH

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 660, 800; 801; 809; 1040 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0577 Prominent-and-Conspicuous-Mark-of-Manufacturers-on-Single-Use-Devices GFI.pdf	https://www.fda.gov/media/71187/download	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 102,758	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	20,447,205	-1,597,520	22,044,725
Annual IC Time Burden (Hours)	8,485,061	-540,090	9,025,151
Annual IC Cost Burden (Dollars)	0	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.