There will be new regulations for the listing of medical devices! FDA will eliminate 510 (K)
Dr. Scott Gottlieb, FDA Director, and Jeff Shuren, Director of Medical Devices and Radiological Health (CDRH), recently issued a statement on reforming the FDA 510(k) regulations to allow the FDA approval path to keep up with the rapidly evolving complex technologies.
The 510(k) document is a pre-market application file submitted to the FDA to demonstrate that the device being applied for is as safe and effective as a legally listed device that is not affected by pre-market approval (PMA), which is a substantially equivalent. To put it simply, the applicant must compare the application for listing with one or more similar devices on the US market to arrive at and support the conclusion of the equivalent device.
The FDA announced that it will introduce a new alternative to 510(k) in 2019. For a predicate device, consider setting a 10-year time limit. The FDA said the move is to implement the medical device safety plan announced by the FDA in April this year.
“The new technologies we see bring great new hope to patients, but advances also bring enormous complexity, making assessment of safety and effectiveness more challenging,†the statement said. “Improvements are made to effectively advance the technology that is beneficial to patients, and to strengthen the FDA's gold standard to ensure safety.
Controversial 510(K) Act
510(k) has been implemented since 1976, but it has been questioned more and more in recent years. The 510(k) bill, which has been approved since 1976, can be reformed at this point in time, and has a lot to do with leading the reform, Jeff Shuren. After he served as director of the CDRH Center in 2011, CDRH made an assessment. Finally, it is recommended that the FDA must completely abandon the 510(k) path.
Previously, the FDA did not agree with these recommendations, but the FDA is constantly improving its policies to encourage innovation, as well as to improve the safety of medical devices and to eliminate old front-end equipment.
On the day before the FDA announced the reform, the results of a public survey conducted by 252 journalists from 36 countries and 59 media outlets were announced by the International Association of Investigators (ICIJ). These news organizations include the BBC and the Guardian. (TheGuardian) and BMJ.
The investigation found that implanted medical devices were not adequately tested before being used by patients, and even some were not tested at all, causing serious harm to patients. The survey also pointed out that according to the US Food and Drug Administration, more than 1.7 million people were injured in the United States in 10 years, and nearly 83,000 deaths may be related to medical devices. In addition, Netflix also launched a documentary "Bleeding Edge" that revealed the truth about the medical device industry in April this year, which caused a lot of attention.
Most people believe that high-risk medical devices implanted in their bodies are marketed after appropriate tests to prove that they are safe and effective, but this is not the case. The US Congress plans to have all new devices undergo premarket approval (PMA). PMA is similar to a new drug, and must be tested in the human body, compiled with all data and submitted to FDA scientists for review.
However, for the medical device industry , new product improvements are made every year, and human tests are performed every time, and the cost is too high. So the Congress established the 510(k) process. In the 510(K) process, manufacturers only need to prove that their equipment is basically equivalent to another device or devices already on the market.
Davie Kessler, the FDA's incumbent director from 1990 to 1997, criticized: "510(k) was originally intended for exceptions and was essentially a loophole, but the exception became the norm. Unfortunately, most of the current medical care Devices are regulated under this framework.†Last year, CDRH approved 3,173 products through the 510(k) process, accounting for 82% of all FDA-approved medical devices.
This led to a vicious circle of medical devices that were basically equivalent to previous medical devices approved, and earlier devices were approved because they were basically equivalent to earlier devices.
Deboran Cohen, editor-in-chief of the British Medical Journal, pointed out in the documentary "Bleeding Edge": "There is a cyclical chain that has finally formed, and you will find that some of the precursor-based devices have been recalled because of defects."
The FDA does not judge pre-base devices. Even if a device is recalled because of danger, it can also be used as a pre-base device to allow the device to be approved as an equivalent device.
However, the FDA said that the data shows that nearly 20% of the current 510(k) is approved based on more than 10 years of predicate devices. This does not mean that the product is not safe. It just means that some devices may not continue to improve and hinder medical technology innovation.
How does the FDA reform the 510(k)
It can be seen from the FDA's statement of announcement that the FDA has also been refining the 510(k) document. With this reform, the FDA hopes to introduce more modern and innovative medical equipment and objective performance standards in 510(k). Specifically, the FDA will eliminate old front-based equipment and introduce objective standards to replace 510(k).
First, the FDA stated in the statement that it will set a 10-year time limit for the base-based equipment, which means that if the equipment manufacturer wants to obtain approval for listing by demonstrating that it is equivalent to the front-based equipment, then the time-based equipment is listed. Must not exceed 10 years.
The statement pointed out that specific measures will continue to advance, and in the coming months CDRH is considering publishing on its website a list of devices that have been listed as equivalent devices for more than 10 years.
The FDA also announced the completion of a guide to establishing an alternative 510(k) pathway in early 2019. The statement states that this alternative approval path will mean that medical device manufacturers will rely on objective safety and effectiveness standards for substantive equivalent verification. The FDA said that this approach updates the way it compares directly with older equipment, and is more conducive to introducing modern standards to support and emerging products.
The new method will be renamed Safety and Performance Based Pathway.
“Through this new approach, device companies can directly prove that a new device is compounded with modern device standards, and the FDA will establish or endorse these standards that reflect current technical principles. We hope that this effective new approach will eventually replace the manufacturer's technology. Compare the new equipment to specific, sometimes old, medical devices."
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