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⚠️ Notice: This information collection may be referencing outdated material.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:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 801 21 CFR 809.30 21 CFR 1040.20

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: 5,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	22,044,725	952	22,043,773
Annual IC Time Burden (Hours)	9,025,151	95	9,025,056
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.