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We are a new Class I medical device and are setting up our…

We are a new...

We are a new Class I medical device and are setting up our Ecommerce website for customers to place orders. The product is listed as prescription only, and thus only registered clinicians are allowed to order it. What process must we follow to allow clinicins to purchase our product?

Lawyer's Assistant: What state are you in? It matters because laws vary by location.

PA

Lawyer's Assistant: Has anything been filed or reported?

Our company is registered with the FDA as a Class I device.

Lawyer's Assistant: Anything else you want the lawyer to know before I connect you?

No - we assume that they would have to put in their medical license # (NPI #). But are we required to?

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Customer reply replied 5 months ago
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Answered in 6 days by:
3/12/2018
WiseOwl58
WiseOwl58, Attorney
Category: Business Law
Satisfied Customers: 4,595
Experience: Senior Associate at White & Case LLP
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The clinician would have to put in their furnishing number (which gives them the right to prescribe). Once the clinician puts in the number, he can place the order.

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Customer reply replied 5 months ago
Is that a requirment of the FDA? Because of the prescription? If we were to remove the prescription status (device is Class I exempt), can we then remove the NPI # to order?

No, it's not FDA required. You can remove the prescription status, then you don't need to collect the NPI.

Please rate five stars ***** by clicking on five stars ***** and press SEND.

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Good luck to you. I wish you all the best.

WiseOwl58
WiseOwl58, Attorney
Category: Business Law
Satisfied Customers: 4,595
Experience: Senior Associate at White & Case LLP
Verified
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Customer reply replied 5 months ago
Thank you! Yes, that is what we decided after speaking to several sources.
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