FDA’s Quick Review of Medical Devices
Attorney
(866) 735-1102 Ext 395
The New York Times recently reported on a way medical device manufactures can get their products on the market quickly, even without proving the effectiveness of the product. When the FDA began regulating medical devices in 1976, they created a type of review process known as a 510(k) review. Since the new medical device regulations would not apply retroactively (to devices already in the market), Congress created the 510(k) review to help disadvantaged manufactures of newer products get their products on the market faster. Basically, the quick review process applies to any new product deemed “substantially equivalent” to something already on the market.
While the 510(k) review process works for devices like band aids or crutches, the review process is also being used for more complex and invasive devices that have a greater impact on patients than just a band aid. For example, the MammoSite system, which is used to treat women with breast cancer by sending radioactive “seeds” into the tumor site, was approved by the FDA after a fast-track review.
The problem is under the 510(k) review, manufactures do not have to prove the products effectiveness for treating patients. With the MammoSite, the manufacturer provided only a 25-patient, four-year clinical trial to the FDA, and while a long-term study is currently in progress, at this point there is no long-term data on the effectiveness of the device.
Critics of the 510(k) review process argue patients need to be told when devices their doctors recommend have not been proven as long-term treatments for the patient’s specific condition. On the other hand, FDA officials point to Mammosite label which warns doctors the treatment is unproved and urge doctors to inform their patients. The 510(k) review has back fired in the past. In 1996, the FDA cleared Protegen, a device to prevent bladder stress incontinence, through the fast review process, but the Protegen was ultimately recalled in 1999 due to a high rate of complications.
In the end, it is important that patients become fully informed about the devices doctors recommend they use.
“Nobody is looking to see whether they help patients,” said Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”