Everything we
wish we’d known
about FDA.
Plain-English guides, expert insights, and practical resources for medical device teams.
Fees current for FY2026 and FY2027
Start here
Curated reading sequences through the open library. Pick the one that matches your seat.
Founder Track
From device idea to documented FDA strategy
RA Lead Track
Standardize how your team writes 510(k)s, risk files, and design history files
SaMD & AI Track
For software and AI/ML medical device teams navigating CDRH's evolving guidance
International Track
Enter the US market from abroad. The whole pathway, in plain English.
Post-Market Track
Your device is on the market. Stay compliant. Survive inspections. Avoid recalls.
Featured Article
The 510(k) process, explained end to end.
From concept to clearance: how classification, predicates, testing, the eSTAR submission, and FDA’s review come together to clear your device.
Start the walkthrough →
The reference library
Fourteen pages in four groups, ordered by the question you arrived with — what do I decide, what does it cost, how do I file, what then. Two of those questions run into a service: a regulatory strategy settles what to decide, and a 510(k) submission covers how to file.
Interactive tools
No account, no email, no limits. Each one states what it does not tell you.
Explainers & long-reads
The reference pages above cover the ground most devices cross. The archive goes narrower — specific devices, specific situations, and questions that come up too rarely for a guide page.
Complizen vs FDA 510(k) Consultants for Faster Clearance
Explore how Complizen's regulatory AI software streamlines the 510(k) submission process, enhancing efficiency while retaining essential human expertise.
FDA Has Cleared 1,614 AI Medical Devices. 96% Took the Same Path.
Explore the FDA's clearance landscape for AI medical devices, revealing key trends, market strategies, and the dominance of radiology in device approvals.
How to Automate 510(k) Submission Tracking for Medical Devices
Learn how to effectively automate 510(k) submission tracking for medical devices, optimizing deadlines and team collaboration while navigating FDA limitations.
Glossary
Every term plain-English defined, cited to the regulation.