Legal Question in Business Law in Texas

Product liabilities

My question pertains to the products I am selling in the US market through my small business. The product I am introducing is a medical devise that is manufactured in India and has not been FDA approved because they have no distributors in the US as far as I understand. I have seen similar products described on the FDA website. My question is whether there are legal liabilities for me and my corporation if I continue to sell these items without FDA approval?

Do you know what actions the FDA can take against the sale of these products? Is there a disclaimer I can use on my website sales listing to avoid any FDA regulation violations?

Thank you


Asked on 5/19/03, 2:20 pm

1 Answer from Attorneys
Peter Bradie Bradie, Bradie & Bradie

Re: Product liabilities

You can either pay to have an attorney research the issue, or you can contact the FDA and ask them. If the device is something that would usually be covered by the FDA, the lack of a distributor may mean that they expect you to pick up the bill for getting that approval.

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Answered on 5/19/03, 2:44 pm


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