The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier.
“External stakeholders” were invited and helped set the agenda. That is what the FDA calls medical device manufacturers who weigh in heavily on the direction the agency takes in approving new medical devices.
Industry lobby group, AdvaMed, told the FDA that things are okay the way they are and there need not be any more regulation.
That is not surprising. Given that most medical devices make it to market via the 510(k) approval process which costs a few thousand dollars and takes a few months, this fast-track mode of marketing is ideal for a medical device manufacturer who wants to reel in profits as soon as possible.
As it now stands, manufacturers still operate under guidelines established in 1997, which impose the “least burdensome” standard on the medical device industry to bring new products to market.
However, without requiring post-market approval, which involves clinical trials, we’ve seen the fallout from 510(k).
Many dangerous metal on metal hips were approved via the 510(k) process.
Most metal hip prosthesis, transvaginal mesh and lap-band implants, were all approved via 510(k) fast track process. The American Medical Association published a 2011 report, “Medical Device Recalls and the FDA Approval Process” and found that of the 113 medical device recalls between 2005 and 2009, 70 percent had been approved through 510(k). Only 21 devices had undergone the more thorough pre-market approval (PMA) process.
In issuing a White Paper prior to this meeting, AdvaMed questioned whether there is any problem with 510(k) that really needs a solution. The White Paper was created with the help of Boston Scientific, reports Mass Device.
The FDA is considering modifying the 510(k) approval process by redefining the “substantial equivalent” definition, imposing periodic reviews of a product post approval or requiring industry to file a new application for approval.
AdvaMed says it believes industry is best qualified to determine if changes to a new medical device might affect safety and efficacy. In other words, it is best qualified to determine how to regulate itself. About 90 percent of the 4,000 devices approved each year go through 510(k).
This meeting was held in preparation for a Congressional hearing in next January when the FDA will be questioned about whether or not to continue allowing 90 percent of medical devices to enter the marketplace with an application and a few thousand dollars.
From 2005-2009, 70% of devices that were 510K cleared, how many people were injured by these devices? That should be the question. Thousands would be the answer! That is what the FDA needs to know and the medical device manufactures, such as Adva Med. ASK US THE INJURED HOW WE FEEL ABOUT 510k!!!!
Maryellen Ramstack, RN
As a patient, victim, advocate the FDA is a 40 year old leaky roof. It has been patched and patched but it keeps leaking. Time for a new roof.
Even the PMA approval of some medical devices is a farce. Point and case Smith & Nephew’s PMA approval of the Birmingham Resurfacing Hip Device. (BHR)
I have asked my Senator, Governor for an honest answer as to how this device was approved. The inventor, investigator, employee of Smith & Nephew received a financial package worth 99 million pounds for the BHR. How is this not a conflict of interest. The same individual used data from a single patient group, one that he solely controlled. There was no test done in the USA. The panel that approved the device raised serious questions as to the unknowns: as with metal particles caused from friction of the hip components entering the human blood. What would happen or could happen there was no answer why because they didn’t really know.
We are seeing what can happen today, however we still don’t know what will happen in the future. The FDA ignored their own policies and rules when approving this device, this is obvious if you read through the application and approval or read the notes from the September 8, 2005 FDA meeting in D.C. held to approve this device.
Much of the data was never verified, the FDA took the word of the inventor, backed up by data that came from his patients. Other data wasn’t allowed to be recognized due to lack of authenticity.
Other manufacturers used this device to get their own devices approved through the 510k process. There are 1000’s of injured patients that are being subject to ridiculous compensation offers from some of these manufacturers. They pay people as if it were nothing more than a traffic fine. Yet the FDA has done little to nothing to correct this problem. There ideas of new rules is hog wash, they can’t control their existing structure how are they going to implement other ideas.
The only way this will ever be corrected is to get the CORRUPTION out.
If the Church, Penn State, Boy Scouts, Oil and Auto industries etc are held accountable for their miss takes and malfunctions how do these manufacturers get a free pass with pre-emption laws when their devices are hurting people.
By the way the only response from my politicians was to contact the FDA as they would be able to answer my questions.
Respectfully
Howard Sadwin ( I have a video on You Tube just type my name Howard Sadwin )