Everything we
wish we’d known
about FDA.
Visual explainers, interactive tools, a glossary of regulatory terms you can finally Google, a newsroom that tracks what FDA actually does — and templates we’d hand to a friend.
Featured this week
The 510(k) flow, end-to-end — every gate, decision, and FDA touchpoint.
From concept to clearance: 14 stops on the most-traveled FDA pathway, with every form and fee in context. Click any stop to dive deep.
Interactive tools
Class finder
Answer 5 questions, get a likely Class I/II/III with reasoning and pathway.
Database explorerPredicate search
Search 510(k) clearances by indication, technology, or product code.
Cost estimatorFDA fee calculator
FY26 user fees by submission type, with small-business reductions.
Plan your pathTimeline builder
Realistic milestones for 510(k), De Novo, and PMA, week by week.
Explainers & long-reads
Does My Mobile Health App Need FDA Approval or Clearance? When Your iOS/Android App Is a Medical Device Explained
Discover if your Mobile Health App needs FDA approval. Learn when a Mobile Health App is considered a medical device and the steps to compliance.
Software as a Medical Device (SaMD) Explained: What It Is, FDA Requirements, and How to Get Cleared
Explore the world of software as a medical device, understand FDA requirements, and learn how to get your software as a medical device cleared efficiently.
FDA’s Latest Warning Letter Mentions AI. Here’s What Actually Matters.
FDA cited AI in a warning letter. Here is what actually happened, why the company failed, and what it means for every team using AI in regulated work.
Learning paths
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.
Newsroom · FDA tracker
Every CDRH guidance, warning letter, and recall that matters — distilled and dated.
FDA finalizes guidance on Predetermined Change Control Plans for AI/ML
The long-awaited PCCP final guidance lands. We summarize what's different from the draft, who it affects, and three things to add to your next AI submission.
Warning letter cites inadequate cybersecurity in connected glucose monitor
A FY26 enforcement action that signals where 524B compliance bites. The 5 specific gaps named in the letter.
FY26 user fee schedule released — small-business 510(k) drops 3.4%
The first decrease in 8 years. A surprise win for early-stage filers. Updated fee table with eligibility rules.
Class I recall: cardiac monitoring software, 14 reported incidents
What the public 21 CFR 806 filing tells us about software change control failures.
CDRH proposes new product code framework for digital therapeutics
A draft restructuring of how DTx are coded. Public comment closes Dec 15.
Glossary · the dictionary RA actually needs
Every term plain-English defined, cited to the regulation, with linked terms for the rabbit-hole.
Premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The most common FDA pathway for Class II devices.
Pathway for novel low-to-moderate-risk devices without a predicate. Creates a new classification regulation if granted.
A legally marketed device used to demonstrate substantial equivalence in a 510(k). Cannot be one withdrawn for safety reasons.
The standard for 510(k) clearance. Requires same intended use plus same OR different technology that doesn't raise new safety questions.
FDA's electronic submission template for 510(k) and De Novo. Mandatory since Oct 2023. Replaces eCopy.
FDA's pre-substantive review checklist. A submission that fails RTA gets bounced before review starts. ~30% fail on first try.
Pre-submission program to get FDA feedback before filing. Free. Adds ~75 days but often saves 6+ months downstream.
Predetermined Change Control Plan. Lets AI/ML devices specify allowed future changes upfront, avoiding repeat 510(k)s.
Software as a Medical Device. Software intended to perform a medical function without being part of a hardware device.
Templates & downloadable resources
Free templates we’ve cleaned up from real submissions. Use them. Edit them. Tell us what’s missing.