Nathan Brown quoted in Medtech Insight on FDA regulatory authority over VALID Act


Overview of medical technologies quoted Nathan Brown, Akin Gump’s healthcare and life sciences partner, in the article “Diagnostics have evolved, so has VALID law, says FDA’s Hillebrenner” .

Brown, who leads the FDA practice at Akin Gump, moderated a panel titled “Diagnostic Reform at a Crossroads: Navigating Through a Pivotal Period” at the MedTech conference earlier this week in Boston, to talk diagnosis reform.

The panel discussed the VALID [Verifying Accurate Leading-edge IVCT Development] An Act to Regulate In Vitro Clinical Testing, Potential Regulatory Reforms and Developments Related to Point-of-Care Testing and Collection Models, Personalized Medicine, Testing for Public Health Emergencies, Test Validation Methods, and what the new MDUFA user fee agreement for IVDs means.

Brown commented on remarks by FDA Commissioner Robert Califf that the FDA could resort to its regulatory authority if Congress fails to pass the diagnostic reforms outlined in VALID. The article says Brown said those remarks were open to interpretation and more along the lines of what the agency “could do, not what it planned to do.”


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