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.
How Long Does FDA Clearance Actually Take for a Taiwanese Manufacturer?
Discover the realistic timeline for FDA clearance for Taiwanese medical device manufacturers, including key steps, challenges, and how MDSAP can expedite the process.
Is Your CE Mark Still Valid? What the MDD to MDR Transition Actually Requires
Ensure your CE mark is still valid under the new MDR regulations. Understand the critical deadlines and what could jeopardize your device's status.
Digital Health Regulation: What Actually Changed at FDA
FDA updates in January redefine digital health regulations, allowing wearables to claim physiological data under wellness guidelines and clarifying software support for clinicians.
Glossary
Every term plain-English defined, cited to the regulation.