FDA and AdvaMed Hold First in a Series of Public Workshops on Postmarket Safety of Medical Devices

The first in a new series of public workshops focused on post-market safety of medical devices should lead to additional steps to improve the reporting of post-market safety data and the application of this information in effective regulatory strategies.

The meeting between the Food and Drug Administration (FDA) and AdvaMed, the Advanced Medical Technology Association, held on February 8th and 9th, is aimed at improving the regulatory processes and oversight of medical devices once they reach the market by gaining a better mutual understanding of current barriers and opportunities to improve postmarket device monitoring and follow-up to further ensure patient safety.

The workshop, “Connecting the Dots on FDA’s Postmarket Safety Activities,” discussed the FDA’s analysis of postmarket trends; industry’s perspective of postmarket issues and regulations; new perspectives on product recalls, removals, and corrections; future trends in postmarket regulation; and industry/FDA collaboration.

“We have established clear goals to promptly identify and analyze adverse events related to devices once they are on the market and to alert device users of potential risks,” said Daniel Schultz, M.D., Director, FDA Center of Devices and Radiological Health. “Specifically, we are strengthening the requirements for industry-sponsored 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 third-party inspections; improving our communications of risk-benefit information to the public and health care providers; and increasing use of automated information systems.”

“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,” said Steve Ubl, AdvaMed President. “We welcome opportunities to work with the FDA to find ways to improve and refine existing systems so that patient safety is ensured, and we offer our extensive expertise and commitment to working with FDA going forward.”

At the conclusion of the meeting, FDA and the AdvaMed participants highlighted some possible areas of collaboration:

Pre and Postmarket 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 lifecycle.

Training -- enhance 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 FDA and the industry on how to achieve compliance with regulations regarding the manufacture of medical devices.

Postmarket Safety Initiative -- provide for industry input into implementation of FDA’s postmarket safety initiatives.

Technology -- greater use of automated information systems to obtain and use data, 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. Future workshops with stakeholders on communications associated with recalls, risk management, and human factors.

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Stephen King

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Food and Drug Administration (FDA)

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