Keynote speaker and panel moderator.
Moving in the Right Direction: Regulatory Progress in Device Clearance & Approval
In recent years, the federal government has placed increased pressure on the FDA to re-examine and improve clearance and approval pathways for medical devices. In turn, the FDA has released numerous draft guidances that directly address approaches for streamlining the review process while elevating the level of scrutiny placed on device submissions to ensure the safety and efficacy of new and existing products. As such, regulatory affairs executives struggle to adequately implement procedures that adhere to developing FDA guidelines due to lack of clear communication and transparency. However, the industry is now undergoing a positive shift as the FDA is placing greater focus on engaging in open dialogue with manufacturers and truly considering industry and legislative concerns, as evidenced by the withdrawal of the 2011 510(k) guidance. This session will highlight recent industry interactions with FDA and how new guidances and the lastes FDA feedback is creating a steadily progressive environment that will ultimately improve the relationship between the agency and the device industry.