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.
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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.
Can Radiology AI Skip the 510(k)? Why FDA Said No
The FDA has denied exemptions for radiology AI devices from the 510(k) process, requiring individual clearances for each device type.
FDA De Novo Database: How to Search It and What It Shows
Learn how to navigate the FDA's De Novo database, uncovering its contents, search methods, and strategies for device classification and approval.
FDA Initial Importer: Who It Is and What It Must Do
Understand the role of an FDA initial importer, its responsibilities, and how it differs from a US Agent in the medical device supply chain.
Glossary
Every term plain-English defined, cited to the regulation.