Your marketing is your label.Keep it inside your clearance.
RegenCompliance for device makers checks product pages, sales decks, and rep materials against FDA device-promotion rules - and against your device's actual cleared Indications for Use. Built for PRP systems, BMAC kits, microneedling devices, and the rest of regenerative medicine.
Where device marketing goes wrong
Three traps that turn copy into an FDA problem.
“Cleared” is not “approved”
A 510(k) device is FDA cleared, not FDA approved. Calling a cleared device “FDA approved” misrepresents its regulatory status, and spinning clearance into an efficacy endorsement (“FDA reviewed and found effective”) is a classic misbranding signal. The scanner catches both directions.
The intended-use trap
Most PRP systems are cleared for a narrow use, like preparing PRP to be mixed with bone graft material. The moment your marketing promotes osteoarthritis, hair restoration, or aesthetics, that claim establishes a NEW intended use (21 CFR 801.4) and makes the device misbranded. Your copy is your label.
Arming your customers
Sales decks and rep scripts that tell clinics what to say to patients hand every customer a treatment claim. If that claim is off-label, you did not just make one violation - you distributed it. The scanner reads collateral the way FDA does: as labeling.
How it works
Grounded in your actual clearance.
Generic rules catch generic mistakes. The device scanner also checks claims against the one document that defines your legal marketing scope: your cleared Indications for Use.
Add your cleared Indications for Use
Paste the IFU from your clearance letter once at setup. It becomes ground truth: every scan checks your claims against your actual cleared scope, not a generic rulebook.
Scan anything you publish
Product pages, sales decks, brochures, emails, trade-show copy. Instant 0-100 score with every risky claim highlighted and explained in plain language.
Rewrite inside your cleared scope
One click pulls claims back inside your cleared intended use, fixes cleared-vs-approved wording, and adds the required statements (Rx only, IFU reference) while keeping your message.
Built for regenerative-medicine devices
The rule set covers the device categories where enforcement actually happens: PRP preparation systems and their narrow bone-graft clearances, BMAC kits and the same-surgical-procedure boundary, SVF and birth-tissue products that are not devices at all but unapproved biologics, and microneedling devices with indication-specific clearances.
Every scan also applies the FTC layer - substantiation for performance and comparative claims, endorsement rules for KOLs and testimonials - plus channel rules for email and sales collateral. This is educational guidance, not legal advice; your regulatory counsel keeps the final word.
FAQ
Device-side questions
Check your collateral
before FDA does.
Founder-beta pricing applies to device accounts too. Apply, pick the device vertical at setup, and scan your first product page in minutes.