Do I need FDA clearance for my medical device? A 5-minute check
A plain-English founder check for whether a medical-device product may need FDA clearance, approval, exemption review, or a different next step.
If your product is intended to diagnose, treat, monitor, prevent, or affect a health condition, do not assume it can be sold without a United States Food and Drug Administration (FDA) review step. The first question is not only what the product is. It is what you claim it does, who uses it, where it is used, and what risk those claims create.
A practical first check is to write down the intended use, buyer, setting, main claims, similar products, and any software or patient-contact features. That gives a consultant or qualified reviewer something concrete to review instead of starting from a blank call.
- Write one sentence for the intended use without marketing language.
- List the user, patient, care setting, body contact, software function, and measurement output.
- Search FDA product codes and 510(k) records for similar products.
- Separate what is known from assumptions that still need qualified review.
- Product description, photos, labeling draft, and claims.
- Known similar devices or competitors.
- Where the device is sold or planned to be sold.
- Any existing test, clinical, software, or risk-management evidence.
- Treating the product name as the regulatory question.
- Ignoring claims made on the website, sales deck, or distributor material.
- Assuming a competitor's clearance automatically covers your product.