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510(k) NSE decisions as evidence of device danger in liability suits challenged by MDMA.

This article was originally published in The Gray Sheet

Executive Summary

510(k) NSE DETERMINATION AS EVIDENCE OF DEVICE HAZARD IN LIABILITY LITIGATION should not be allowed, the Medical Device Manufacturers Association argues in a May 24 amicus curiae brief submitted in the case of Reeves v. AcroMed, currently pending before the U.S. Fifth Circuit Court of Appeals. Weighing in on behalf of AcroMed, MDMA says that a 510(k) "not substantially equivalent" decision by FDA "does not affirmatively find that a risk or other problem actually exists with a device" and therefore "cannot be evidence" that a device poses unreasonable danger per se.



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