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FDA summarizes LDT rule requirements in new compliance guide
27 June 2024
Hogan Lovells 2024 Election Impact and Congressional Outlook Report
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.
Awards and recognitions
2020
Band 1 for Healthcare and Healthcare: Pharmaceuticals/Medical Products - District of Columbia
Chambers USA
2019
Highly Recommended for FDA Medical Devices
LMG Life Sciences
2018-2019
Regulatory Firm of the Year
LMG Life Sciences Awards
