(PRINTWORDS NEWS) On Friday, the scientists of National Academy of Sciences came forward with a report that says that the Food and Drug Administration (FDA) should not permit thousands of medical devices to be sold and used by the patients without a perfect proof of effectiveness and safety.
The report also states that FDA should be extra careful while approving the medical devices. However, the reviews for many devices are accelerated as they are considered to be similar to the previous devices in the market. Hence, it has been recommended in the report to abolish the previous system of approval and establish a new one.
David Challoner, the chairman of Institute of Medicine (an arm of National Academy Of Sciences) that wrote this report said that it is not yet clear if the process would serve the “needs of either industry or patients, and simply modifying it again will not help”. On the other hand, FDA has opposed to this recent study but asked for an analysis from the researchers.
The members of National Academy of Sciences claimed if the medical devices fail to serve their purpose, they can generate serious health problems, which might even harm their lives. “What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device”, David Challoner said in his statement. Last summer, more than 90,000 artificial hips were recalled from the market after it was found out that about 1 out of 8 users needed to replace them.
Institute of Medicine called this fast approval process as 510 (k). Regarding this study, the director of FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren told that FDA completely understands and believes that this 510 (k) process should not be excluded. However, he also added that FDA is “open to additional proposals and approaches for continued improvement of our device review programs”.
