For private-label personal lubricant and condom brands and their contract makers

The lab renewed in October. The brand didn’t.

Charter keeps each establishment behind your products — brand owner, contract maker, relabeler — with every fiscal year’s registration and fee, and each device’s 510(k) and listing, and will not clear a product to ship for a fiscal year while anything behind it is missing.

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Opens in this browser with an invented brand already in it. No account, no email address, nothing installed.

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The problem

One product, three establishments, three renewals.

Personal lubricants and condoms are Class II medical devices cleared through a 510(k). Every establishment that makes, specifies or relabels them registers with FDA every fiscal year and pays the annual fee, and lists each device. A private-label product usually has more than one establishment behind it, and each renews on its own.

Class II

personal lubricant, product code NUC, cleared by 510(k).

FDA product classification, NUC →

$13,785

the annual establishment registration fee for FY 2027, October 1, 2026 to September 30, 2027.

FDA, MDUFA fees →

Every year

each establishment registers again for each fiscal year — separately from the brand on the box.

21 CFR 884.5300 →

Will not clear a product that is not registered and listed.

Not a reminder. Clear to ship refuses, naming each gap, while a device has no 510(k) or listing number on file, no establishment linked, any linked establishment has no registration recorded for the fiscal year, or a foreign establishment has no US agent. A clearance is frozen for its year. There is no override.

How it works

Establishments, devices, the new year

Record each establishment

Its role, its registration number, and for a foreign one, its US agent.

Record each device

The product code, the 510(k), the listing, and every establishment behind it.

Renew and clear

As each establishment registers for the new fiscal year, record it — then clear each device to ship.

What it will never do

It keeps your calendar. It files nothing with FDA.

Charter uses the numbers and confirmations you give it.

No FDA connection.Nothing is filed or looked up. You type from FDA’s own confirmations.

It holds no passwords.Your FDA account details stay where they are.

It is not regulatory advice.It is the calendar and the check.

It never touches a payment.The subscription is for software.

Pricing

Priced per brand

A rounding error on one registration fee.

Most brands

Brand

$29/month

One brand and its makers.

Every establishment and device
Clear-to-ship gate, no override
Fiscal-year calendar

Contract maker

$79/month

A maker tracking its brand customers.

Everything in Brand
Many brands
Export per customer

Monthly subscription. Your bank statement says Charter Software. Your licence key is emailed to you within two working days of payment.

Checkout is our own bitcoin server, not a card processor — nobody we had to apply to and nobody who can close the account. The button takes you straight to it. Give your email address there — that is where your key is sent.

Questions

The ones we actually get asked

When is the registration due?

Each fiscal year, from October 1. Charter flags any establishment without a registration recorded for the current fiscal year, with the end of December as the date it counts down to.

Does the brand owner have to register if a lab makes it?

Often, as a specification developer. Ask your regulatory adviser; Charter tracks whoever you add.

Is this regulatory advice?

No. It is the calendar you keep, and a check you cannot skip.

What do I actually get when I pay?

The demo on this page is the whole program, running on invented records. Paying gets you a licence key — one line of text, emailed to the address you give at checkout within two working days. Paste it into the program and from then on it keeps your own records. Until then, nothing you type into it is kept.

The key is checked inside the page, on your own machine. It never calls us, so there is still no account and nothing about your business goes anywhere. If you ever stop paying, your records stay exactly where they are, read-only, and Export still hands you every one of them.

Open the demo before December

Both contract makers registered for the new fiscal year in October. The brand owner has not, so neither lubricant nor the condom can be cleared — and the silicone lubricant is still waiting on its 510(k) either way.

Open the demo See pricing