Supreme Court Hears Medtronic Case

But Medtronic and the industry associations who have intervened on its behalf argue that the PMA process is much more thorough, and that for state courts to undermine FDA's authority to ultimately determine safety and effectiveness would throw the whole system into chaos.Specifically at issue is wording from the Medical Device Amendments Act of 1976, which does not allow states to impose on manufacturers "any requirement which is different from, or in addition to, any requirement applicable under this chapter." Since 1992, the high court has interpreted the word "requirement" to include damage awards by state courts. "Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access to these life-saving and live enhancing products," said AdvaMed General Counsel Christopher White in a statement released by the trade group.The plaintiff's attorney argued that premarket approval is a preliminary judgment of safety and effectiveness, not an ultimate one, and so manufacturers should not be relieved of any obligations to make their products better.