Posts Tagged 510(k) clearance
I received an e-mail about a new laser device for cellulite. The PR statement hypes its “510(k) FDA Clearance.” I laugh a little. That means the device is so similar to something else already on the market that it does not need more formal FDA approval. Sounds earth shattering…..:)
What is 510K?
The FDA’s 510(k) clearance process is a way for devices (by showing how similar they are to already approved devices) to avoid the more stringent formal FDA PMA process. In essence it is a short cut. So 510K is FDA code for “same old stuff.”
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing…
When I see 510K I read “this device is re-hashed technology to the extent it does not need formal FDA approval.” My already substantial doubt in new devices then climbs to even higher than my usual nuclear cynic level.
People need to know when product literature proclaims FDA approval that it does not mean it works. It generally means that it is at least as safe as other technology on the market.
Now the device can always prove me wrong……
John Di Saia MD
Originally posted 2012-02-02 07:30:21.
Laurie Kelly of Irvine, diagnosed with breast cancer, went in for a new kind of intra-operative radiation treatment at Hoag Hospital in Newport Beach in June 2010. However, tungsten from the shield used to protect her healthy tissue shed into her body, and Kelly decided to get a double mastectomy. The manufacturer recalled the Axxent Flexishield in February 2011 after the breasts of 10 women were contaminated with fragments of tungsten. The number has since risen to 29.
We have discussed my misgivings with the 510(k) FDA Clearance before. This Axxent Flexishield product had apparently been given this type of approval by the FDA. Now there are women with tungsten particles within them that had apparently been inadvertently shed from a shield used in the process.
The 510K pathway is a short cut in the FDA approval process for technology that is viewed as substantially equivalent to technology already out there. Calling something equivalent without further study is a judgment call that has a risk element within it. The tungsten particles within the breasts of some of the women who had this treatment are that risk element manifesting itself.
New treatment comes with new and different risks than treatments with a long track record. I tell my patients this each time they tell me of something that is “cutting edge.” There is an edge that cuts for you and an edge that cuts against you. New treatments often do not have substantial understanding of that second edge. When these new technologies have been given abbreviated evaluation by the FDA, people are going to be angry. Some of them are going to sue.
I hope the women with these embedded tungsten particles do not turn out to have significant morbidity. A new uncertainty in breast cancer treatment is not welcome news to any breast cancer survivor.
John Di Saia MD