Class I Exempt FDA Question


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Hello, if a product is Class I 510K Exempt IVD Device would it need a clinical study to be marketed to the FDA?

The product is selective differential medium enables isolation and identification of clinically important species.

Parul Chansoria

Regulatory and Quality Expert
Hi @jbm12 you've asked a good question here, and I'd say that this is something manufacturers should ask inspite of being exempt from 510(k) requirements, and not consider themselves exempt from all requirements if they are exempt from a 510(k). Here is some information to help address your question.

Mandatory obligations:
I believe you must be aware of many mandatory obligations for class I exempt product like the post market reporting, labelling compliance, and all requirements that may apply to you as per your product code.

Clinical study and 510(k) exemption:
An exempt Class I product is considered a low-risk device, and hence typically does not require a clinical study to be marketed in the US. However, this one rule does not apply to all products, and depends on the novelty of your product, technology, the current standard of care, available information (published or real world data) for such a clinical application, and the claims and indications for use you want to pursue for your medical device.

Applicability for your product:

Like you said your product is a "selective differential medium that enables isolation and identification of clinically important species", this type of selective differential medium can play an important role in microbiological diagnostics by providing a controlled environment for the isolation and identification of clinically important microorganisms. Through this isolation and identification, healthcare professionals can diagnose infectious diseases and build appropriate treatment strategies. Now, if you are making claims around "diagnosis" or "helping guide treatment strategy" then a clinical study should be considered and there should be a strong justification for not doing the study. However, if your device is intended for laboratory use and will not directly impact patient diagnosis or treatment then it is unlikely that a clinical study would be required. Another thing to think of is when you begin making such claims for an exempt product, it may not stay in the exempt category anymore and due to the claims, clinical usage and indications the product may be classified under a higher risk category, hence, it is important to revisit the applicable regulatory requirements with change in product's design, material, indications, etc.

Hope this helps.

Parul Chansoria


Starting to get Involved
@Parul Chansoria Hello, what if the product is specifically stating for the use in diagnostic workflow to aid clinicians in determining potential treatment options?
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