Device manufacturers argue that the FDA regulatory process has become too long and too unpredictable for companies to stay in business in the U.S. and has forced them to take their business overseas. Such a move, they say, hurts American patients’ access to the latest medical treatments. On the other side of the argument, consumer advocates say the FDA clearance process is much too quick and poses serious patient safety risks, according to the news report.
Jeffrey Shuren, FDA device director, says it’s not that the FDA clearance process is “slower” than Europe. Unlike the FDA, European regulators do not require devices to be proven to successfully treat disease, which leads many devices to be recalled for safety issues, he said.
Read the news report about the FDA approval process.
Read other coverage about the FDA:
– FDA Approves EndoSerter Device for Corneal Transplants
– Johnson & Johnson and FDA Clash Over Rejection of Sedative
– FDA Releases Final Rule on Software, Hardware Used With Medical Devices
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