Unfortunately, every once in a while, a medical device that has been FDA approved has shown signs of health risks long after the final approval decision was made. Whilst everyone makes mistakes, we can’t afford to be too forgiving when it comes to matters like this. After all, it is up to the FDA to ensure our health and safety when it comes to modern day medical devices. Which leads to the next question, how much can you really trust the FDA?
The Purpose of FDA
The purpose of this massive organisation is to guarantee that the medical devices we come in contact with are completely safe and effective to use. They conclude such matters by carrying out a formal assessment of the product, otherwise known as the 510(k) clearance process. This involves testing and examining the device before allowing it to be released onto the market.
FDA Accredited Persons
Many people get a little confused when it comes to the Accredited Persons Program. This program was created by the FDA to assist and hasten the 510(k) reviewing process. The main reason being to lessen the time period that it takes for the FDA to approve a device.
How long does it take to get a FDA 510k approved?
The FDA can take up to several months, or longer, to analyse and finalise the approval of a medical device. Because of this, the FDA advises people to take advantage of the Accredited persons program to hurry the process along. Organizations such as FDA Third Party Review will provide a more efficient and less expensive route towards achieving your 510(k) clearance.
History of Unsafe Medical Devices
Unfortunately, unsafe medical devices have emerged in the market over the years. A few years ago, when a device which was used as a permanent birth control device for female users entered the market, many women experienced serious health problems. This was one of the more serious cases, as noted by Healthable, and was later unapproved by the FDA and labelled as a black box device. This basically means that the device is unsafe to use and will not be allowed back onto the market. Other medical devices considered unsafe in the past include knee implants, hip implants and catheters. Patient safety is of the utmost importance to the FDA, which is why as soon as previously approved devices are deemed harmful, they are immediately removed from the market and “black listed”.