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Medical Device Amendments

A Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices

In 1976, Congress passed the Medical Device Amendments (MDA) to charge the FDA with reviewing the safety and effectiveness of medical devices. The MDA heavily regulates high-risk medical devices that are capable of supporting human life through a premarket approval process. Read what a litigation associate in BakerHostetler’s Houston office advises.

Continue ReadingA Conflict in the Interpretation of the Medical Device Amendments: Developing a Preemption Test for Hybrid Medical Devices