Pros and Cons of FDA's Medical Device Reporting rule
This article was originally published in Clinica
Executive Summary
The final US Medical Device Reporting rule "imposes considerable burdens on domestic and foreign manufacturers for which civil and criminal penalties will be pursued", warns Medical Device Manufacturers Association (MDMA) counsel Larry Pilot. Although the final rule provides manufacturers with more time and some greater flexibility to determine what is subject to a report, the FDA estimates that the number of reports will increase by 50% to 150,000. "This alone suggests a significantly greater burden and liability for company personnel, in particular executives."