MoCRA Lite

Prepare for a MoCRA compliance consult

How to prepare questions before hiring a MoCRA consultant or attorney.

What this page helps you check

MoCRA Lite keeps the validation page focused on one practical decision. Use this guide with the live tool at /launch/mocra-lite when you need a fast estimate, a saveable checklist, or an early conversation with the product team.

Where the estimate stops

The output is intentionally bounded. It is useful for triage, planning, and interview prep, but it is not a substitute for a professional review, lab analysis, legal advice, medical advice, or a final launch approval.

FAQ

Questions before you save the result.

Is this legal advice?

No. MoCRA Lite is a triage checklist for early validation. It helps a maker decide what to review next before speaking with qualified counsel or a regulatory consultant.

Does likely exempt mean I can skip MoCRA?

No. It means the answers resemble a small-business exemption path, subject to exceptions and product details that still need review.

Why do you ask about eye, injected, internal, and long-wear products?

FDA describes product categories where small-business exemptions do not apply. The tool flags those answers as review-needed instead of giving a green light.