FDA Medical Device Classification & Regulatory Pathway Report
A written report on your product's likely FDA device class, product code and route to market.
- 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
Before selling a medical device in the US you need to know its FDA class and whether it needs a 510(k), is exempt, or needs another route. We research the classification regulation and product code, check exemptions and predicates, and give a written pathway report with next steps and fee notes. Testing and labs are excluded. £380 per device.
What's included in your pathway report
| Document | What it is |
|---|---|
| Device or not | Whether the product is a device, cosmetic or drug in the US |
| Classification | Likely class, regulation number and product code |
| Pathway | 510(k), 510(k)-exempt, De Novo or other route |
| Requirements | Registration, listing, labelling, UDI and QMSR obligations |
| Fee notes | Current FDA user fees for the identified route |
Who this report is for
- Makers of tampons, menstrual cups and pads
- Beauty device brands such as LED masks and microcurrent tools
- Cosmetic brands unsure if a product is a device
What this report does not include
- Testing. Laboratory testing, lab fees and test reports are not included.
- A 510(k) or other submission.
- An FDA decision. The report is our assessment; only FDA can confirm a classification, for example through a 513(g) request.
- FDA fees.
How it works
- Send your product Description, intended use, materials and claims.
- Research We search FDA's classification database and comparable devices.
- Report You receive the written pathway report.
How are medical devices classified in the US?
Under FD&C Act section 513, FDA places devices in Class I, II or III by risk. Each type has a classification regulation in 21 CFR Parts 862–892 and a product code. Many Class II devices need a 510(k) premarket notification, while some are exempt. For example, tampons are Class II and need a 510(k); menstrual cups are Class II but exempt; unscented pads are Class I and exempt. Every route still needs establishment registration and listing.
FDA fees we note (FY2027)
Current FDA user fees:
- 510(k): $28,653, or $7,163 for a qualifying small business.
- Annual establishment registration: $13,785, with no small business reduction.
Fees are paid by you to FDA and are not part of our price.
What you receive
- Written pathway report
- Classification regulation and product code
- List of next steps and estimated FDA fees
Legal framework
- FD&C Act section 513 — device classification
- FD&C Act section 510(k) — premarket notification
- 21 CFR Part 807 — registration, listing and 510(k)
- 21 CFR Part 884 — obstetrical and gynaecological devices, including menstrual products
Official sources:
Why brands choose Phoenix
- Cosmetic, drug or device — we check all three.
- Fee figures up to date for FY2027.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Know your route before you spend. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Do tampons need a 510(k)?
Yes. Tampons are Class II devices that need a 510(k) premarket notification.
Do menstrual cups need a 510(k)?
No. Menstrual cups are Class II but exempt from 510(k). They still need registration, listing and correct labelling.
What is the FDA 510(k) fee?
$28,653 for FY2027, or $7,163 for a qualifying small business. It is paid by you and not included.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
Is the report an FDA decision?
No. It is our assessment. Only FDA can formally confirm a classification.
How much does the report cost?
£380 per device.