FDA – Medical Devices
Label and Content Review
Fee: $349 / product
Medical device labels follow the rules in 21 CFR Part 801. The label of a packaged device clearly states the name and place of business of the manufacturer, packer or distributor. The instructions for use must be adequate for the user to use the device safely and for its intended purpose.
Who Is Obligated?
Manufacturers and labelers of medical devices to be sold in the United States.
What We Do
- We review the label and instructions for use against the rules in Part 801.
- We report the gaps in the UDI, manufacturer details and warning statements.
- We prepare the corrected English label text.
What You Receive
- Review report
- Corrected label text
US Medical Device Label Review Application
Device and label details for reviewing your medical device labels and instructions for use against 21 CFR 801.
Frequently Asked Questions
- Which company details must appear on a device label?
- The label of a packaged device clearly states the name and place of business of the manufacturer, packer or distributor.
- Are the instructions for use included in the review?
- Yes. The instructions must be adequate for the user to use the device safely and for its intended purpose; we review them together with the label.
- How should the UDI appear on the label?
- We check the placement of the UDI on the label and packaging during the review. If you do not yet have a UDI, we address it together with our UDI / GUDID service.
Sources: 21 CFR 801.1; 21 CFR 801.5; 21 CFR 801.20.