On Wednesday, January 19, the U.S. Food and Drug Administration (FDA) announced changes to the process used for allowing most medical devices to be marketed, commonly referred to as the 510(k) process.  Section 510(k) of the Food, Drug, and Cosmetic Act allows lower-risk medical devices to be marketed if they are “substantially equivalent” to devices already on the market.

Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health said the changes announced Wednesday would result in "a smarter medical device program that supports innovation; keeps jobs here at home; and brings important, safe and effective technologies to patients quickly. We look forward to implementing these changes in support of our overall mission: improving the health of the American public."

The 510(k) system has been criticized in recent years by several constituencies.  Industry has viewed the system as unpredictable, inconsistent and opaque, which discourages investment and stifles innovation.  Consumers, third party payers and some health care professionals have expressed concern that the system is not sufficiently robust to assure that devices are safe and effective.  In addition, there is increased concern that the 35-year old 510(k) process is simply not well-equipped to handle the increasing complexity of today’s medical devices.

To address these concerns, the FDA started an internal and external evaluation of the 510(k) process.  Wednesday’s announcement is the result of the internal evaluation by FDA.  Later this year, results of the external evaluation (conducted by the Institute of Medicine, the health arm of the independent National Academy of Sciences) will be released.

Among the changes FDA announced that it will implement to foster innovation:

• A streamlined review process for innovative, lower-risk products, called the “de novo” process;
• Guidance to clarify when clinical data should be submitted as part of the review process;
• Development of a network of external experts to help the agency address important scientific issues regarding new medical device technologies; and
• Establishment of  a Center Science Council of senior FDA experts to assure more timely and consistent science-based decision making.

Changes FDA announced that it will implement to bolster medical device safety include:

• Establishment of a public database of device information, such as medical device labeling and summaries of the basis for the FDA’s decision to clear specific devices; and
• Requiring a brief description of scientific information regarding the safety and effectiveness for higher-risk devices.

The agency committed to create new draft guidances, make internal process changes, and launch a series of programming and regulatory programs by the end of 2011.

Some of the more controversial issues related to the 510(k) process were not addressed by the new changes; instead, FDA referred these issues to the Institute of Medicine’s independent evaluation.  As noted, the results of this evaluation are due later this year.  Some of the issues the independent report will address include:

• Clarification of when FDA can fully or partially rescind a product’s 510(k) clearance;
• Clarification and enhancement of the agency’s authority to require post market surveillance studies; 
• Definition of a new subset of devices that will require more data and evaluation to gain 510(k) clearance; and 
• Clarification of the agency’s authority to consider off-label uses when determining the intended use of a device.

Generally, reaction to the proposed changes has been positive.  Stephen J. Ubl, president of AdvaMed, which is the largest US trade association of medical device companies, called the proposals “a good first step.”  He noted, however, that “the critical next step is how FDA implements the plan through guidances and regulations. Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.”

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