Food and Drug Administration Medical Device Overhaul The Food and Drug Administration is proposing a revamp of its regulations of medical devices, according to a report it released Wednesday. While seeking to improve device safety, the FDA also wants to ease the regulatory process and foster device innovation, it said. Such changes could have a major impact on device manufacturers such as Medtronic (MDT), Boston Scientific (BSX) and General Electric Healthcare (GE).

In its overview, the FDA looked at whether its process clears devices without sufficient evidence of their safety and effectiveness. It also examined whether its process itself lacks predictability, consistency, and transparency, which may be hindering device development and delays their entrance to the market.

Medical devices range from items as simple as tongue depressors to complex programmable pacemakers and laser surgical devices, or diagnostic products, such as lab equipment and test kits. Certain electronic radiation-emitting products, such as CT scanners, ultrasounds and X-ray machines also meet the definition of medical device. They are regulated by the FDA's Center for Devices and Radiological Health.

Concerns Over the Medical Devices Review Process

The FDA is responding to concerns specifically raised about its current review process for low-risk to moderate-risk medical devices -- the 510(k) program. This much cheaper review process is for new products that are similar to previously approved devices, and roughly 4,000 submissions are handled under it each year. But even high-risk devices have been cleared under this process, as the Government Accountability Office found in its report from January 2009.

The FDA became concerned about the program after it cleared under the 510(k) rules a knee implant made by ReGen Biologics (RGBO). Despite concerns that clinical data didn't show the implant to be any better than the standard operation for meniscus injury, the device was approved after pressure from the manufacturer and lawmakers.

Some of the FDA's recommendations include: improving the regulatory pathway for lower-risk novel devices; making better use of scientific experts outside of the agency; defining a subset of moderate-risk devices for which clinical or manufacturing data typically would be necessary thus preventing delays; and establishing a Center Science Council.

What Constitutes 'Substantial Equivalence'?

Surprisingly, data regarding the safety and effectiveness of a device under review isn't always required despite the dynamic health environment we live in. Among the recommendations is such a requirement. Further, the FDA will require developing guidance documents to clarify when a device should not be used.

And the FDA also aims to be more consistent and transparent when it comes to the question of what constitutes a similar product, or "substantial equivalence." For example, ReGen asserted that its implant is substantially equivalent to Johnson & Johnson's (JNJ) shoulder implant and Stryker's (SYK) soft-tissue repair matrix.

The 510(k) standard has been applied to a wider range of devices over time, notes Dr. Jeffrey Shurren, Director of the CDRH in the report, including "increasingly varied, complex, and potentially higher risk technologies. The need for greater clarity has become even more pressing."

Good or Bad for Industry?

Reaction from the Advanced Medical Technology Association (AdvaMed), a trade group representing the roughly $200 billion U.S. device industry, wasn't late in coming. While the group itself has often criticized the current process for its lack of consistency and predictability, it is also worried about the additional costs companies may have to incur due to additional regulatory requirements, not to mention the possibility that fewer devices will clear the higher regulatory hurdles.

"On first reading, FDA's report includes a number of commendable steps to improve the 510(k) process," including the small subset of the moderate-risk devices, said Stephen Ubl, president and CEO of AdvaMed. But the over 70 proposed changes "could result in a significant disruption to a program that has served patients well for more than 30 years." He points to two independent reports that show the strong safety record of the 510(k) process.

The FDA, however, doesn't believe any of the requirements would mean any "significant additional burden" to the companies or that less devices will have access to the 510(k) process, and some analysts believe the better clarity could even smooth the process.

Recently, the FDA has started to crack down on medical devices: For example, Baxter International (BAX) was recently required to recall 200,000 infusion pumps from the U.S. market.

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