An analysis of the latest medical device reporting (MDR) requirements for manufacturers by Jonathan Kahan
This article was originally published in Clinica
Executive Summary
The US FDA's final rule revising the medical device reporting (MDR) requirements is due to come into effect on July 31st, 1996. The final revisions to the MDR regulation are unusual in several respects. First, in an era of congressional criticism of burdensome FDA regulations, the new MDR requirements impose several new extremely burdensome and costly requirements on industry.