In the long term, we are in the process of building a collaborative National Evaluation System for health Technology (NEST). We can also order companies to conduct postmarket surveillance studies of a class II or class III device if we have new concerns about a product's safety. This is why the FDA uses a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices, including analyzing reports of problems that are submitted to our public database, reviewing results from Post-Approval Studies, and evaluating the available clinical literature. Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice. However, not all information regarding benefits and risks for a given device are generally known before the device reaches the market. Regardless of which process is followed, the FDA strives to permit marketing of only those devices with a favorable benefit-risk profile. There are various processes that the FDA uses to review information about medical devices before they can be marketed in the U.S. Devices are classified as Class I, Class II, or Class III, Class I being the lowest risk and Class III the highest risk. Medical devices are classified based on the risks associated with the use of the device. Within CDRH, the FDA regulates a wide range of medical devices, including, pacemakers, cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests and relatively simple devices such as tongue depressors and elastic bandages. The mission of Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is to assure that patients and providers have timely and sustained access to high-quality, safe, and effective medical devices and safe radiation-emitting products. If your segment addresses additional points from the film, please let us know as we would be happy to provide additional comments to address any inaccuracies in the film. We are not aware of whether any of the information we provided was used in this project to provide a more balanced viewpoint of medical devices. The FDA has not had the opportunity to see this documentary, but we did provide extensive responses to the filmmakers' questions, part of which we are providing below. Statements to CBS News regarding "The Bleeding Edge" from the FDA, Bayer (reproduced here in part), Johnson & Johnson, Essure and the Advanced Medical Technology Association are published below: FDA they didn't know this information," Ziering said. It has information you simply can't get anywhere else. And one of the big problems with a lot of these studies is Essure's implanted for life but these studies often followed women only for a short time, a year, year and a half, and a lot of these symptoms come up five, 10, 15 years later." In Bayer's response to the film's claims about Essure, the drug maker cites "40 published studies involving approximately 200,000 women over two decades," which are not discussed in The Bleeding Edge." Asked to address the omission of those studies, Dick said, "Most studies are actually funded by industry and as a result they're very, very biased. "Ninety-eight percent of devices can be approved for sale without any studies in humans, meaning we are guinea pigs and we don't know it," Ziering said. Horrific glimpses of animal slaughter reveal the cruelty man can unleash upon creatures lower on the food-chain, and authentic autopsy footage indulges our morbid curiosities about our final stop on the way to the grave.The Bleeding Edge | Trailer | Netflix by Gross as our guide, we bear witness to death in its many forms - even visiting a debauched death cult that mixes the ecstasy of sex with the sweet release of that final moment. From airplane crashes to railway disasters, some of us meet a spectacular end while others fall prey to hungry wildlife predators, an assassin's bullet, or - as in the case of some condemned prisoners - get strapped into the electric chair and blasted into the afterlife with over 2000 volts of pure electricity. There's simply no escape from the encroaching darkness, and in this film we're offered a firsthand glimpse at the many ways that life can end. Everybody dies - it's the fate we all face from the moment we're born. Francis Gross (Michael Carr) leads viewers on a guided exploration of that fateful moment when the spark of life is brutally snuffed out. Experience the ultimate in cinematic shock and horror as Dr.
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