FDA2013年批准3000种新的医疗器械，40种有安全和有效的临床证据

FDA2013年批准3000种新的医疗器械，40种有安全和有效的临床证据。其他只需显示和已经上市的器械相似就可以了。 新药一年批30种。每个都要有安全和有效的临床证据。。。


http://blogs.wsj.com/briefly/2014/12/15/how-medical-devices-like-morcellators-get-to-market-the-short-answer/
The Short Answer

How Medical Devices Like Morcellators Get to Market

10:30 pm EST Dec 15, 2014

By

Jon Kamp

and

Thomas M. Burton

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The FDA warned last month that doctors shouldn’t use surgical cutting tools called laparoscopic power morcellators to remove common uterine growths in the “vast majority of women” because they could worsen hidden cancers. The stark announcement capped nearly a year of FDA review. But it also came 19 years after the FDA first approved a power morcellator for gynecology, as The Wall Street Journal reports, raising questions about how the FDA’s regulatory system works.

• How does the FDA approve medical devices?

  For most devices the federal regulatory agency approves, the manufacturer mainly has to show the product is similar to something already on the market. These devices may go through lab and animal testing, but clinical testing in humans is generally not undertaken. Of the roughly 3,000 new devices the agency approved in fiscal 2013, about 40 went through a more involved approval process that typically requires clinical-trial evidence to show they are safe and effective and may include a review by a panel of experts.

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• How does that differ from the FDA's drug-approval process?

  The FDA approves about 30 drugs a year, and they are rigorously tested in clinical trials to demonstrate they’re safe and effective. Most often, these drugs go through at least two human studies in which patients are randomly assigned to the new drug or to a control group getting a placebo or standard therapy.

• Does this device-approval system work?

  Janet Trunzo, senior vice president, technology and regulatory affairs at the Advanced Medical Technology Association trade group, says the streamlined system is “overwhelmingly safe” and gets needed medical advancements to patients. But the system has garnered criticism over the years, notably from the esteemed Institute of Medicine. After the FDA asked it to review the system, the institute in 2011 called for scrapping the device-approval system. Dr. William Maisel, the FDA medical-device center’s chief scientist, says that the approval process is a good way to “balance innovation and safety.”

• Did these approval rules play a role in power morcellators?

  Power morcellators reached the U.S. market through the FDA’s less stringent device-approval process. Experts say that even the agency’s tougher review process likely would have missed the problems that eventually sparked the FDA’s warning that morcellators can worsen hidden cancers, and that such cancers are far more common than many doctors realized. Human trials for medical devices are often too small or too brief to catch this kind of effect. The FDA’s Dr.  Maisel says only an extremely large clinical study could have turned up early evidence of the morcellator’s risks and that FDA didn’t act because “the agency and the clinical community didn’t have an appreciation of the risks of cutting presumably benign fibroids.”

• What can be done to improve the device-approval system?

  The FDA has long been working on improvements to its surveillance system for approved devices. Some experts have called for holding devices to higher safety and effectiveness standards, and for a greater use of randomized, controlled studies of medical devices used on humans.

  The FDA has long been working on improvements to its surveillance system for approved devices. Some experts have called for holding devices to higher safety and effectiveness standards, and for a greater use of randomized, controlled studies of medical devices used on humans. The FDA’s Dr. Maisel say the agency is strengthening its surveillance of devices on the market.