Everything we
wish we’d known
about FDA.
Plain-English guides, expert insights, and practical resources for medical device teams.
Fees current for 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.
What Is GMLP? FDA’s 10 Good Machine Learning Practice Principles
Explore the FDA's GMLP principles for AI medical devices, covering development, testing, and performance monitoring to ensure safety and effectiveness.
FDA Clearance for AI Devices From Korea, Japan and Taiwan
How AI medical devices from Korea, Japan and Taiwan get FDA clearance: what carries over from MFDS, PMDA or TFDA, US data needs, PCCPs and review times.
AI Tool Validation Under the QMSR: How to Validate AI Tools and Keep Audit Trails
How to validate AI tools under the QMSR: FDA’s 2026 software assurance guidance, risk levels, what to record, Part 11 audit trails and AI model changes.
Glossary
Every term plain-English defined, cited to the regulation.