FDA Meeting Points to Industry Collaborative Ventures

Focusing on the post-market safety of medical devices, the U.S. Food and Drug Administration (FDA) met in early February with AdvaMed, the Advance Medical Technology Association in the first of a new series of public workshops. The aim is to improve reporting of postmarket safety data and application of the information in effective regulatory strategies.

To share information and insights, the workshop, "Connecting the Dots on FDA's Post-market Safety Activities," discussed the Agency's analysis of post-market trends as well as industry's perspective on issues and regulations. Participants examined new perspectives on product recalls, removals and corrections as well as future trends on post-market regulation. Too, industry collaboration with the FDA was discussed.

As reported by FDA, seven areas of possible collaboration are:

• Pre- and post-market regulation - - better coordination and integration within FDA and within companies of the pre- and post-market processes to ensure consistency, quality and safety throughout the product life cycle.
• Training - enhancement of training for industry and FDA staff on quality systems, conduct of post approval studies, device recall processes and reporting of postmarket adverse events.
• Recalls  increase industry's understanding of FDA's expectations for when a device should be recalled for a malfunction or adverse events, thresholds for when actions should be taken and how the public should be informed.
• Good Manufacturing Practices  greater collaboration between the FDA and industry on how to achieve compliance with regulations regarding the manufacture of medical devices.
• Post-market Safety Initiative  provide for industry input into implementation of the FDA's postmarket safety initiatives.
• Technology - greater use of automated information systems to obtain a n d u s e d a t a , including electronic submission of marketing applications.
• FDA activities with industry and other stakeholders - working groups on recalls, annual reports, condition of approval studies and unique device identifiers. Further workshops with stakeholders on communications associated with recalls, risk management and human factors.

Daniel Schultz, M.D., director of the FDA Center of Devices and Radiological Health, notes that, "Specifically, we are strengthening the requirements for industrysponsored studies once their devices are on the market; improving our targeted surveillance systems to identify adverse events; enhancing our risk-based approach to inspecting manufacturing sites, including implementing thirdparty inspections; improving our communications of risk-benefit information to the public and health care providers; and increasing use of automated information systems."

For its part, Steve Ubl, AdvaMed president, says, "The medical technology industry is committed to providing safe and effective devices and recognizes the value of FDA's role in ensuring device safety both before and once a device is on the market."