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Medical Devices › Licensing Rules › Food and Drug Administration (FDA)

Hogan Lovells

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

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State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more

Gardner Law

State Licensing Requirements: Are You Prepared?

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Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

Foley & Lardner LLP

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

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Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

Foley & Lardner LLP

Software as a Medical Device: Challenges Facing the Industry

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Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more

White and Williams LLP

Montana Significantly Revises Its Product Liability Laws

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On May 4, 2023, Montana changed its product liability laws when the Governor signed SB 216, which was effective upon passage and applies to claims that accrue on or after May 4, 2023. Among the changes is the adoption of a...more

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