Findings from an industrywide 510(k) study conducted by researchers at Northwestern University and funded by Washington, DC-based InHealth (Institute for Health Technology Studies), are significant, yet hardly surprising. More than 350 professionals engaged in medical device development participated in the online survey, which was discussed during a recent (5/24) webcast . Talking points included:

• 76% found preparation requirements for a 510(k) submission to be uncertain or unclear.
• 72% felt that information requests from FDA reviewers went beyond the requirements established in guidance documents.
• 59% reported no guidance documents existed for their devices.

These findings, along with many others, prompted FDA’s Jeffrey Shuren to outline action items now underway at the agency where he serves director of the Center for Device and Radiological Health. These included a range of updated and new guidances to clarify CDRH requirements for timely and consistent product review; ramped-up reviewer training that will include time spent with manufacturers, research and healthcare facilities, and academia; more opportunities for meetings with FDA reviewers; continued harmonization efforts and sharing of best practices between Europe, Canada, Australia, and Japan; targeted allowances to help overcome staff turnover; and clearer and timelier industry notice letters communicating when new scientific information is required for a type of device.

For more on the survey and the webcast, visit see the Medical Design Perspectives blog titled, “FDA’s Shuren responds to latest 510(k) survey with action items.

Then, visit www.medicaldesign.com to answer this month’s Reader Poll question:
Is FDA effectively addressing industry concerns over the 510(k) product review process? Last month’s Reader Poll question asked, Have you let lawmakers know your views on the medical device tax, 510(k) reform, or other industry-related issues?” A slight majority (52% of Medical Design readers said they have; 26% said no, they have not; and 20% said no, but that doing so is on their “to-do” list).