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Regulations in the medical field are generally tougher than in most other areas. For example, Xultophy, a new drug which will control blood sugar much better, will probably be available in more than one year, because of extensive trials.
When we take the results provided by medical testing devices to presume help us get healthy. One of the crucial stages of developing medical testing devices and release them on the market is the laboratory testing. But are the companies doing enough to provide products which only improve patients’ health? Are the lab tests designed safe enough to avoid future harm? The FDA is not sure they do. This is why the regulators released an announcement on Thursday by which they reinforce their goal ensuring only accurate, consistent and reliable results will back medical diagnostics.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”
Medical testing devices must be produced under stricter regulation
Of course, companies producing medical testing devices are not keen on the announcement. They usually argue that more regulation stifles innovation and lengthens the product development process. The FDA is aware of this and said it will introduce the regulations in a wide timeframe to allow industry adjustment, the Washington Post notes. There is one exemption to the new set of directives. Medical testing devices used to diagnose rare diseases will be exempted from the new set of regulations, if the rules render the development costs unsustainable.
FDA noticed some problems in the recent past with medical testing devices released on the market. The breast cancer risk test taken with a device produced by Myriad Genetics, produced some legal concerns over patent issues last year. The problem is that some medical testing devices go through extensive lab testing, while others do not. So to level the field, the FDA wants to impose regulations so the market will only have thoroughly tested medical machines. In the same time, companies will not think about skipping or skimming the lab test to cut costs. The patients will only gain from such a measure on the long run.