On November 8, 2016, the FDA released final guidance on Medical Device Reporting (MDRs). MDR is a critical quality component of a company’s complaints management system. All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to it.
The controversial medical device excise tax of 2.3% that was enacted as part of the Affordable Care Act was suspended, albeit temporarily for two years. What does this tax mean to the medical device manufacturers?