Health Law Consulting Blog

Monday, March 26, 2018

FDA Regulated Products and Technology 101

In this fast-paced, global contracting environment, traditional due diligence is a thing of the past. Therefore, we have found that ascertaining certain information upfront serves as a form of due diligence that cannot possibly be done in isolation. This allows us to know that the request relating to Regulated Products (as defined below) has been properly vetted (i.e. gone through a robust legal, regulatory, and compliance review as deemed appropriate) and all necessary approvals were obtained confirming the concept the contract relates to is not deemed to violate any applicable law, including the anti-kickback statute and false claims act.  In the alternative, if such robust legal, regulatory or compliance review was deemed unnecessary, an attestation to this effect can state so with a simple explanation why such reviews were deemed unnecessary.

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Disclaimer: The information in this blog post (“Post”) is provided for general informational purposes only, and may not reflect the current law in your jurisdiction. No information contained in this post should be construed as legal advice from Faulk & Associates, LLC or the individual author, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this Post should act or refrain from acting on the basis of any information included in, or accessible through, this Post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country or other appropriate licensing jurisdiction.


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