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FDA Compliance

More Stringent FDA Review Processes for Medical Devices on the Horizon

The FDA prepares to review and revise the 510(k) process.

Published: Monday, March 8, 2010 - 16:09

After years of focusing on the pharmaceutical industry and establishing better controls for reviewing the safety and efficacy of pharmaceutical products prior to approval, the Food and Drug Administration (FDA) is now directing its attention to the medical device industry.

On Feb. 18, the FDA held a day-long meeting to address the 510(k) system, which it has used for more than three decades to review and clear medical devices to be sold in the United States. The 510(k) refers to the section of the Federal Food, Drug and Cosmetic Act that requires manufacturers of medical devices to notify the FDA of their intent to market a medical device at least 90 days in advance. Also known as premarket notification, the 510(k) process is intended to be applied to devices that are similar to products currently on the market.

Therein lies the crux of the issue—as ever-more sophisticated and complicated medical devices are being created, more and more “high risk” devices (those that are life-sustaining and/or implanted in the body) are slipping through the cracks and being approved under the 510(k) process, even though they may share only a trivial similarity with a device already being sold.

Complicating matters is that some 510(k) product reviews are being funneled to third-party reviewers. In its Feb. 17 issue, The Wall Street Journal alluded to an internal FDA memo from Dec. 22, 2009 in which the agency cited concerns that such reviewers may not have the necessary expertise to conduct a proper 510(k) assessment and may instead take a submission at face value instead of conducting a thorough analysis. In fact, the FDA memo suggested that limitations may be placed on what devices will be eligible for third-party 510(k) reviews.

The 510(k) route to approval is popular among medical device manufacturers, because it is faster and less expensive; products classified as wholly new must go through more rigorous testing as part of a new device application (NDA) for FDA approval. Every year approximately 3,500 devices are approved under the 510(k) system, compared to about 50 products approved as new devices.

Larry Kessler, Sc.D., former director of Science and Engineering for the FDA’s Center for Devices and Radiological Health, was quoted by The New York Times, also on Feb. 17, as saying, “The device world codified by the Medical Device Amendments of 1976 [was] dramatically different than where we are today 35 years later. The pace of innovation has really ramped up and the 510(k) process has been used, and in some cases people would say misused, to clear very advanced technology.”

Although its scrutiny of the pharmaceutical product review and approval process was prompted by Vioxx-related complaints, the FDA is acting proactively now as it prepares to review and revise the 510(k) process. This move is widely viewed as part of the Obama administration’s efforts to make medical-related products safer for consumers.

Prior to the Feb. 18 meeting, the FDA asked the Institute of Medicine (IOM) to compile a report on the issue of medical device approvals. The IOM describes itself as an “independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public.” The kind of independent report requested by the FDA is a prerequisite for drafting new regulations, and many in the industry see the FDA’s request as a harbinger of changes to the medical device approval process. It is anticipated that the report won’t be completed until March 2011.

STAT-A-MATRIX has a variety of ways to help you understand and navigate the 510(k) process, including the seminar 510(k) Process for Medical Devices which explains the history, procedures, and requirements of 510(k). The company also offers consulting on 510(k) submissions to help organizations at every step of the process, even if the process is revised by the FDA.


About The Author

Oriel STAT A MATRIX’s picture


Since 1968, Oriel STAT A MATRIX has delivered billions of dollars of increased profitability by helping organizations drive revenue and reduce costs. Oriel STAT A MATRIX is a global leader in consulting and training related to performance improvement and regulatory compliance. It has helped hundreds of companies throughout the world effectively develop the potential from within their organizations to successfully integrate and deploy performance improvement principles and practices, and to meet organizational, regulatory, and strategic goals.