Medical Product Label Requirements

General Device Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code. If the firm's street address is...

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). General Device Labeling - 21 …

Quality System Regulation Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements

eCFR :: 21 CFR Part 801 -- Labeling

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801

( 1) A device identifier - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and ( 2) A production identifier - a …

Medical Device Labeling: Regulatory Requirements for Medical…

https://tulip.co/blog/medical-device-labeling/

Requirements of a medical device label In the US, the FDA stipulates that a label must be present on the immediate container and additional packaging on the item. …

Medical Device Marking and Labeling - mddionline.com

https://www.mddionline.com/regulations/medical-device-marking-and-labeling

Medical Device Marking and Labeling: Cleaning, Sterilization, and Maintenance Instructions Table III. Internal markings (click to enlarge). An operator's manual is required to provide information on …

United States Product Labeling Requirements: An …

https://www.compliancegate.com/united-states-product-labeling-requirements/

Product Packaging Labeling Requirements. If you import or manufacture products in the United States, you may be required to abide by relevant product packaging labeling requirements established in acts and …

Labeling Requirements - Other Labeling Exemptions | FDA

https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-other-labeling-exemptions

The person introducing the product into commerce is not the operator, and the delivery is to be made under a written agreement which includes the names and addresses of the firms …

Compliance FAQs: Packaging and Labeling in the US

https://www.nist.gov/standardsgov/compliance-faqs-packaging-and-labeling-us

The UPLR requires that consumer packaging bear a label specifying the following: the identity of the commodity the name and place of business of the …

Medical Device Labeling Requirements - I3CGLOBAL

https://www.i3cglobal.com/medical-device-labeling/

Devices with a presence of carcinogenic, mutagenic, or toxic to reproduction (CMR) substances must declare on the label. All devices that incorporate a medical substance or tissues/cells or their derivatives must clearly …