“Dramatic and unprecedented changes are unfolding in the medical device industry thanks to the intense scrutiny being placed on the Food and Drug Administration’s 510k process to clear certain medical devices for sale in the U.S. marketplace,” writes Celestica’s Nancy Duarte-Lonnroth in the May issue of Medical Design.  The author is director of quality, regulatory affairs, healthcare for the Toronto, ON-based contract manufacturer.           

In response to President Obama’s efforts to minimize public risk and with the spotlight now firmly on the FDA’s approval process, medical device manufacturers are already scrambling as they prepare to navigate through more rigid requirements without delaying their time to market.

Duarte-Lonroth says the reality is that the 510K clearance process is about to become much more rigorous and will in most cases translate into significantly more time and money being spent by manufacturers and OEMs to keep up. The author has much to say about how organizations can prepare for the coming 501k changes.