FDA Registration & 510(k) Without a Consultant

Your U.S. buyer asks, “What’s your FDA status?” — and you don’t know where to start.

FDA’s website is huge, in English, and every link leads to another link. This guide puts the scattered FDA source documents in the order you actually do the work, so you can see the whole picture before asking for a consulting quote — and do yourself what you can do yourself.

Who it’s for

• Export, quality and RA staff at medical device companies taking on the U.S. for the first time

• People at small and mid-size manufacturers preparing a 510(k)

• Anyone who wants to learn the terms and steps before talking to a consultant

Who it’s not for

• Registrations outside the U.S. (EU MDR etc.) — this book covers U.S. FDA only

• Drugs, food or cosmetics — medical devices only

• Writing or reviewing your submission for you — this is a book, not a consulting service

What you’ll be able to do

1. Find your product code and confirm with FDA databases whether your path is exempt, 510(k), De Novo or PMA.

2. Handle establishment registration (FURLS), the annual registration fee and your U.S. Agent, step by step, as a foreign manufacturer.

3. Choose a predicate and prepare eSTAR, recognized consensus standards, labeling and the small business fee reduction.

4. Respond to each FDA email after submission — K-number, the 180-day AI request window, the final decision.

5. Stay on top of UDI, Medical Device Reporting, QMSR and change control after clearance.

What’s inside

• Checked against FDA originals — numbers, sections and dates rechecked on November 10, 2026 against eCFR, the Federal Register and FDA’s website, with sources at the end of every chapter.

• Real timelines, not just goals — next to the 90-day goal, the actual 510(k) average from FDA’s performance report (141 days for FY 2023 submissions).

• What changed this year — the FURLS login passcode, the credit card payment limit, and the draft MDUFA VI commitment letter for the next five years, as of November 2026.

• Real FDA screens — database and website screenshots with red boxes showing what goes where.

• 16 “At a glance” diagrams — classes and pathways, fees, product codes, reporting deadlines and other easy-to-confuse points, each on one page.

• From the field — moments where a practicing RA manager got confused or had to redo something.

• 16 common mistakes, a checklist for every chapter, and a one-page checklist from day one to the first year after clearance.

• Appendix — 27 FDA website and database shortcuts and a 73-term glossary.

About the author

Cleared — the author’s pen name, taken from the word FDA uses for a device that passes 510(k) review. More than 10 years in regulatory affairs across pharma and medical devices; a practicing RA manager.

Good to know

• Current as of November 2026 (QMSR effective February 2, 2026; FY 2027 fees). FDA fees change every October 1 and guidance and screens can change — check the sources listed at the end of each chapter before you submit.

• A practical guide, not legal advice.

• 155 pages, fixed A4 page layout.