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December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure. In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.
“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”
On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.
On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.
FDA Letter to Health Care Providers
Posted by the FDA on April 25, 2018.
The Issue: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.
Permanent birth control is one of the most widely used methods of contraception today. It can be highly effective, doesn’t require a surgical procedure and women no longer have to remember to take a daily pill. So why has the FDA restricted the sale and distribution of the Essure device and required boxed warnings?
Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.
February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling. If this occurs, patients may need a revision surgery to remove or replace the device.
It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?
The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Unfortunately, in recent years, drug and product recalls have become more common. Why? What happens and how does the process work? Who is responsible for making sure these products are adequately tested before hitting the market?
Questions? Our knowledgeable staff is available at (877) 284-6600.