Former FDA Counsel Philip Desjardins Featured in MedTech Strategist on First Post-Election De Novo Authorization
Philip Desjardins, Life Sciences & Healthcare Regulatory partner and former official with the FDA’s Center for Devices and Radiological Health (CDRH), was recently quoted in MedTech Strategist’s article, “The First Post-Trump De Novo Authorization: Reassuring, But Questions Remain.” The story discusses the FDA’s recent authorization of Nanosonics’ Coris platform via the De Novo pathway — marking the first De Novo granted under the new administration.
Desjardins called the decision encouraging but noted the need for more data before drawing broader conclusions. “An ‘N’ of one is better than an ‘N’ of zero, but we still don’t know,” he said. “That’s what we are going to be paying attention to over the coming months.”
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