Executives used to lean toward European regulators launching their products in that region. But after a decade of change, they now see the U.S. as a better option. While the FDA gets kudos, the other issue remains challenging: reimbursement.
Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for connected devices, Software as a Medical Device (SaMD), and the go-to market strategies for the companies behind them.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
The Medical Device Regulation’s objective is to improve patient safety by evaluating existing devices and ensuring transparency throughout a device’s lifecycle once it has gone to market. Some experts predict that up to 50% of medical devices could be taken off the market as a result of it.
By Allyson B. Mullen – On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially change the underlying requirements […]