Substantia tells you whether your device needs a 510(k), finds the predicates to compare against, checks your standards and audits your eSTAR before FDA does. Built by a team of regulatory and software engineers.
NewUse Substantia yourself. Join early accessResults within one business day. Fixed price, quoted before you start.
Example result for a fictitious device
real FDA 510(k) decisions used to test Substantia
to get your results, from pathway check to eSTAR audit
checks on every eSTAR, each finding verified by our regulatory engineers
Answers in minutes instead of weeks of manual research. The pathway check, predicate finder and standards check are fully automated. eSTAR audits are verified by our regulatory engineers before delivery.
Does your device need a 510(k), is it exempt, or does it need a De Novo? Substantia works out which device type fits yours and whether a 510(k) exemption applies.
The cleared devices most like yours, grouped by product code, with their indications, standards and testing laid out so you can compare.
Every standard you cite, checked for whether FDA currently recognizes it, in which edition, and in full or only in part.
Your eSTAR and every attachment checked against what FDA's technical screening looks for, so it isn't put on hold for something that could have been fixed in an afternoon.
Self-serve access is on its way: run a pathway check, find predicates and check your standards whenever you need to, without sending a single email. Join the early-access list and be first to try it.
Prefer not to upload? Done-for-you checks by email stay available, as they are today.
Substantia covers each step a 510(k) device takes on its way to filing, so nothing is left until the last week.
Find the product code, regulation and device class that fit your intended use.
510(k), exempt or De Novo, with the conditions that decide it.
Find the cleared device to claim equivalence to, and see how others did it.
Confirm every standard is one FDA recognizes, in the right edition.
Catch what technical screening would catch, before FDA sees it.
Not sure where you are? Tell us what you have so far, and Substantia will tell you the next step… free of charge.
Tell us about your deviceBefore substantive review begins, FDA checks that an eSTAR submission is complete. A missing signature or an empty required section is enough to stop it there.
The clock stops while you fix it and resubmit. Weeks of your launch plan go to problems that could have been found in an afternoon.
Its own completeness check can't tell that your labeling contradicts your Indications for Use, or that a standard is cited in an edition FDA no longer recognizes. Reviewers can.
Each finding says what was found, where, which FDA requirement or guidance it relates to, and what to do about it.
21 CFR 807.87(l)
eSTAR technical screening
FDA guidance on consensus standards
21 CFR 807.87(f)
21 CFR 807.87(e) and 801.109
21 CFR 807.92
An optional AI-assisted review reads the attachments for problems fixed checks can't express, such as a clinical study that doesn't cover the ages your indications claim. It runs only with your agreement, and every AI finding is labelled as such in the report.
The sample is a full audit of a fictitious infrared ear thermometer, in the same format, checks and wording as a real report. Email us and we'll send it, usually the same day. Real reports are confidential to the client.
Resolve before filing, review before filing, or ready to file, with the findings to start on.
Every section and part, whether it applies, and its status in the eSTAR's own check.
What we found, the evidence, where it is, the FDA source, and what to do.
Every file, where it is attached, and whether it could be read.
Every check performed, the FDA data used and when it was retrieved.
Email the filled eSTAR PDF with its attachments. We sign your NDA first if you need one.
Substantia reads the form, its saved state and every attachment, and runs the full set of checks.
Each finding is checked by hand. False alarms are removed and context is added where it helps.
A PDF report within one business day, and a call to walk through it if you want one.
Filing your first 510(k), or filing without a full regulatory team. Get an independent check before the submission leaves your hands.
A second pair of eyes on a client's eSTAR before you file it. Reports can be prepared for your firm to pass on to your client.
No. Substantia gives your team an analysis: it points to specific issues and the FDA sources behind them, and decisions about your submission stay with you.
No one can guarantee clearance. The audit reduces the chance of a hold for completeness and consistency problems. It does not judge whether your test methods or results are scientifically adequate.
Yes. Start with a pathway check to confirm what FDA will expect, then use the predicate finder and standards check as your design and testing take shape. You only pay for what you use.
Non-IVD eSTAR versions 5.5 through 7.0. If your file uses a version FDA has retired, the report says so.
The filled eSTAR PDF as you would submit it, with its attachments embedded. Nothing else is needed to start.
Yes. Findings you fix or decide to set aside move to an appendix with your reason, so the updated report shows what changed.
A fixed fee for each check; the audit depends on the size of the submission. You get the price before you send any files.
Email us and we'll reply within one business day with a fixed price and a delivery date, or the next step if you're still early.
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