Area of focus

State Medical Device Distribution & Manufacturer Licensing

Medical device manufacturers that distribute prescription and over-the-counter (OTC) devices are subject to complex state licensing requirements that can attach to their manufacturing and/or...

Representative experience

Assisted client in addressing state licensing for new product launches by identifying those states that required licensure and assisting the company in preparing those applications.

Negotiated enforcement discretion with states for medical devices where licenses may have been required under the letter of the law, but the states elected not to require licensure due to the low risk of the product and low benefit of licensure.

Assisted companies with developing remediation strategies and handling notices of violations from state regulatory bodies.

Assisted in the negotiation of distribution agreements with client distribution partners and 3PLs to ensure that state licensing obligations were met.

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