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The future of the 510(k) process

Thomas Novelli

by Thomas Novelli, Director of Federal Affairs for the Medical Device Manufacturers Association

Fresh off the heels of healthcare reform, medical device manufacturers are now facing new challenges at the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency that regulates the industry.

Ask most device manufacturers who have submitted a 510(k) application over the past 18 months, and they will likely tell you about regulatory hurdles unlike any experienced in their professional careers. The agency is reviewing the process responsible for providing regulatory approval for the majority of medical devices.

Startup and established companies alike have experienced noticeable slowdowns in their device applications to the FDA. While pre-market approval (PMA) devices have always required significant clinical data and scrutiny by the agency, the 510(k) clearance process has been a recent target for critics with claims that not enough data is being provided to the agency.

Critics have also suggested that the 510(k) clearance route has become a “fast-track” mechanism for novel medical devices, bypassing the more rigorous PMA process.

Over the last few years, the criticism of the way the FDA handles device approvals has grown louder. The agency that handles device approvals seems to be under constant pressure from outside sources, including so-called patient advocacy groups and members of Congress.

Many point to a group of rogue reviewers from the CDRH as the origin of the current climate affecting device approvals and clearances. In the fall of 2008, a group of eight unidentified reviewers from the agency sent letters to Members of Congress and the Administration critical of the review process and the way managers within the agency address scientific agreements. While the eight reviewers only represent a small fraction of the total CDRH workforce, their message appears to have been heard loud and clear.

Their letters referenced serious deficiencies in the regulatory process for medical devices and said that the process itself had become “seriously distorted.” Building upon this assertion, the group charged that certain agency officials had acted illegally by putting patients at risk by clearing devices despite objections from scientific reviewers. The group further claims that reviewers who disagreed with an approval or clearance of a device were retaliated against by senior agency officials because of their dissent.

Reviewing concerns

The reviewer outcry, combined with other elements and pressures against the agency, has led the agency to take several actions to address the concerns. In 2009, the agency issued an internal memo highlighting the actions of the CDRH in light of the controversial clearance of an orthopedic product. The memo pointed to potential lapses by the agency and became the catalyst for a “top-to-bottom” review of CDRH. Specifically, following the release of the memo, the agency contracted with the Institute of Medicine (IOM) to provide a comprehensive review, with recommendations, of the 510(k) clearance process. In preparation for the IOM report, the Institute will hold several public meetings to obtain public comments and is expected to issue its final report to Congress in 2011. Parallel to the IOM report, the FDA is also conducting a comprehensive internal overview and of the 510(k) clearance process and is expected to issue a report prior to the IOM report.

Uncertainty affecting

So what does all this mean for the medical device industry? Does the 510(k) process need significant and extensive reform? Many regulatory experts would conclude that the answer is no. Practical experience suggests that products reviewed under the 510(k) process are safe and effective and, more importantly, the 510(k) process is the correct regulatory pathway for the majority of devices. However, the current actions by the FDA have generated an unprecedented level of uncertainty and lack of predictability for device manufacturers. Unfortunately, this uncertainty and lack of predictability is having a significant and disproportionate impact on startup device companies — especially those that rely on the infusion of venture capital to fund their commercialization process. Many companies are choosing not even to commercialize in the U.S., instead taking their products to commercialization in the European Union or elsewhere. Others that are enduring the process here in the U.S. are burning through capital at an alarming rate.

The FDA is expected to release internal findings and recommendations on the 510(k) process over the next few weeks. This will likely set the initial stage for broader reform of the regulatory pathway. Whatever the outcome of the findings, device manufacturers should be ready to adapt for change.

Thomas Novelli is Director of Federal Affairs for the Medical Device Manufacturers Association. He can be reached at tnovelli@medicaldevices.org.