Medical Device Label, IFU & UDI Review (FDA)
A review of your device label, instructions for use and UDI against FDA labelling rules.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Medical device labels sold in the US must meet 21 CFR Part 801, and most need a unique device identifier under 21 CFR Part 830. We review your label, instructions for use and UDI, including special rules such as tampon absorbency and TSS warnings, and mark up required changes. Testing and labs are excluded. £740 per device.
What's included in your label review
| Document | What it is |
|---|---|
| Label | Name and place of business, intended use and required statements under 21 CFR 801 |
| Instructions for use | Adequate directions, warnings and precautions |
| UDI | Device identifier format and GUDID data points |
| Special rules | Such as tampon absorbency ranges and TSS warnings (21 CFR 801.430) |
| Recheck | One recheck of revised labels |
Who this review is for
- Makers of tampons, menstrual cups and pads
- Beauty device brands
- Foreign manufacturers adapting labels for the US
What this review does not include
- Testing. Laboratory testing, lab fees and test reports are not included. Absorbency and other claims need test evidence.
- GUDID account setup or issuing-agency fees.
- Label design.
- FDA fees.
How it works
- Send your materials Labels, IFU, packaging and intended use.
- Review We check each element against FDA rules.
- Report You receive marked-up labels and IFU.
- Recheck One recheck is included.
What do US medical device labels need?
21 CFR Part 801 sets FDA device labelling rules: the name and place of business of the manufacturer, packer or distributor, adequate directions for use, and warnings. 21 CFR Part 830 requires most devices to carry a unique device identifier (UDI), with data submitted to GUDID. Some devices have specific rules, such as tampons, which need absorbency ranges and toxic shock syndrome information under 21 CFR 801.430.
What we check
Label:
- Identity and intended use.
- Manufacturer details.
- Rx or OTC status.
IFU:
- Directions, warnings and contraindications.
UDI:
- Device identifier and production identifiers.
What you receive
- Marked-up label and IFU
- UDI review notes
- One recheck
Legal framework
- 21 CFR Part 801 — device labelling
- 21 CFR 801.430 — tampon labelling
- 21 CFR Part 830 — unique device identification
Official sources:
Why brands choose Phoenix
- Label, IFU and UDI in one review.
- Menstrual product experience from our GPSR work.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Fix your device labels before launch. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
What must a US medical device label include?
The name and place of business of the manufacturer, packer or distributor, adequate directions for use, required warnings and, for most devices, a UDI.
What is a UDI?
A unique device identifier on the label, with device data submitted to FDA's GUDID database.
What must tampon labels include?
Absorbency terms and ranges and information about toxic shock syndrome, under 21 CFR 801.430.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
Is a recheck included?
Yes, one recheck of revised labels.
How much does the review cost?
£740 per device.