Lisa Virgen Scrutinizes Premarket Approval Process for Medical Devices

News / February 22, 2022

Associate Lisa Virgen authored an article published by Medical Device News Magazine on Jan. 25, 2022, titled “A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices.” The article covers the premarket approval (PMA) process required by medical device manufacturers to show that a high-risk device is safe and effective with “reasonable assurance” before they can introduce the device to the market; the conflict within existing case law involving the issue of hybrid medical devices and preemption to the PMA process; and suggests a proposal to harmonize conflicting case law to determine when preemption applies to a hybrid medical device.

Read the article.

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