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It's generally recognized that discussion of harmonization at US FDA over the past several years has resulted in senior FDA personnel dividing into two factions: an "old guard" that regard European and Canadian device regulation as broadly ineffective and see harmonization as likely resulting in a weakening of US FDA device oversight, and a group of proponents who believe that a well-managed process could strengthen all of the involved systems. I don't think Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, previously has been on record as to his stance on harmonization.
In comments during a conference call with reporters regarding the FDA's 510(k) initiative, Shuren is reported by MedCity News to have said:
My take would be that these comments clearly imply that Dr. Shuren has serious doubts as to harmonization, and likely would want substantial changes in the MDD's underlying device performance expectations. As the head of CDRH, my understanding would be that Dr. Shuren has considerable influence and probably effective control over any harmonization activities undertaken by US FDA.
In comments during a conference call with reporters regarding the FDA's 510(k) initiative, Shuren is reported by MedCity News to have said:
“What we’re proposing today is to address that uncertainty and to keep us a leader in medical innovation for many years to come, while at the same time — and this is critical — assuring that devices are safe and effective,” he said. “There are a number of differences between us and the European Union — they have a different standard than we do. Here in the U.S., the device has to be safe and effective. In Europe, a device has to be safe and it has to perform.
“For example, if I have a laser that’s supposed to treat an abnormal heart rhythm — you cut into the heart — in Europe, you have to show that when it cuts the heart, it cuts the heart well. In the U.S., you have to show when it cuts the heart it actually treats atrial fibrillation. It treats the abnormal heart rhythm — that patients get a benefit out of it.”
That said, Shuren noted, the U.S. does a better job of protecting patients from potentially harmful devices.
“We also have to remember, ‘Let’s not throw the baby out with the bathwater,’” Shuren said. “Here in the U.S., devices are safe and effective, but in many cases — and we have a number of examples — devices that came on the market in Europe, when they had to show data here for the U.S. we found they have safety concerns, where they didn’t work and they came off the market in Europe thereafter.
“I’ll leave this with a quote regarding one particular technology that was recently removed from the [EU] market. It was a breast implant that never made it here [in the U.S.]. This is from Nigel Mercer, a former president of the British Assn. of Aesthetic and Plastic Surgeons. He recently stated that, ‘Under the EU system, the public are being used as guinea pigs.’ We don’t use our people as guinea pigs in the U.S.”
It's interesting to note that these comments make indirect reference to recent discussions about ISO14971 and the FDA's use of risk analysis. The FDA's relatively new Total Product Life Cycle analysis and Assurance Case Report requirements for certain moderate-risk devices appear to be a change of focus away from ISO14971-style analysis of risk, which it may be the FDA sees as too often only loosely related to safety and effectiveness as the FDA defines them, and toward a more rigorously direct requirement for evidence-based analysis of safety and effectiveness.“For example, if I have a laser that’s supposed to treat an abnormal heart rhythm — you cut into the heart — in Europe, you have to show that when it cuts the heart, it cuts the heart well. In the U.S., you have to show when it cuts the heart it actually treats atrial fibrillation. It treats the abnormal heart rhythm — that patients get a benefit out of it.”
That said, Shuren noted, the U.S. does a better job of protecting patients from potentially harmful devices.
“We also have to remember, ‘Let’s not throw the baby out with the bathwater,’” Shuren said. “Here in the U.S., devices are safe and effective, but in many cases — and we have a number of examples — devices that came on the market in Europe, when they had to show data here for the U.S. we found they have safety concerns, where they didn’t work and they came off the market in Europe thereafter.
“I’ll leave this with a quote regarding one particular technology that was recently removed from the [EU] market. It was a breast implant that never made it here [in the U.S.]. This is from Nigel Mercer, a former president of the British Assn. of Aesthetic and Plastic Surgeons. He recently stated that, ‘Under the EU system, the public are being used as guinea pigs.’ We don’t use our people as guinea pigs in the U.S.”
My take would be that these comments clearly imply that Dr. Shuren has serious doubts as to harmonization, and likely would want substantial changes in the MDD's underlying device performance expectations. As the head of CDRH, my understanding would be that Dr. Shuren has considerable influence and probably effective control over any harmonization activities undertaken by US FDA.