How do quack devices get FDA approval?
What is required for FDA approval, and how do quack devices like the sculptone http://www.vactherapy.com/ get it?
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I couldn't find anything on an FDA approval for the device using the search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
The FDA goes through the process of getting a device approval at their "Device Advice" site here: http://www.fda.gov/cdrh/devadvice/3122.html
Here is my basic understanding, that I'm sure may be lacking. FDA "approval" is required if you are marketing a device as something that diagnoses, treats, prevents or mitigates disease. Thus, your electrical units for "muscle conditioning" won't need an FDA approval, but the same device for "treatment of pain" does.
510(k) approvals are easiest to come by. Here, the device is merely riding the coat-tails of a device already having FDA approval, or being marketed since before a certain date. The only proof required is that the function and labeling (how you use it or the way it interacts with body tissue) be essentially the same as the predicate device.
Medical vacuum pumps have been around in medical care for eons, it probably wouldn't be too hard to get a 510(k). In fact, like a hospital bed, perhaps you can get one UL listed, be clever in the wording in your promotions, and suddenly you're selling them to unscrupulous medical practices! But, you are now in a gray area, and the vactherapy site is beyond gray, in my opinion. Also, in my opinion, a clinician is committing fraud by reporting and billing payors for use of this device.
On a huge side-bar, there's an intriguing story playing out concerning equipment for vacuum therapy for wounds. Seems one company developed, researched, submitted to the FDA, and marketed a system for vacuum wound therapy. Ultimately, they got their own AMA CPT codes and CMS RVU's for very lucrative reimbursement of their proprietary device. Now, it seems, some in medicine are figuring out this very expensive treatment is really no more than simple suction on the wound - something that could cost a mere fraction of what the proprietary device is currently getting.
dras
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I couldn't find anything on an FDA approval for the device using the search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
The FDA goes through the process of getting a device approval at their "Device Advice" site here: http://www.fda.gov/cdrh/devadvice/3122.html
Here is my basic understanding, that I'm sure may be lacking. FDA "approval" is required if you are marketing a device as something that diagnoses, treats, prevents or mitigates disease. Thus, your electrical units for "muscle conditioning" won't need an FDA approval, but the same device for "treatment of pain" does.
510(k) approvals are easiest to come by. Here, the device is merely riding the coat-tails of a device already having FDA approval, or being marketed since before a certain date. The only proof required is that the function and labeling (how you use it or the way it interacts with body tissue) be essentially the same as the predicate device.
Medical vacuum pumps have been around in medical care for eons, it probably wouldn't be too hard to get a 510(k). In fact, like a hospital bed, perhaps you can get one UL listed, be clever in the wording in your promotions, and suddenly you're selling them to unscrupulous medical practices! But, you are now in a gray area, and the vactherapy site is beyond gray, in my opinion. Also, in my opinion, a clinician is committing fraud by reporting and billing payors for use of this device.
On a huge side-bar, there's an intriguing story playing out concerning equipment for vacuum therapy for wounds. Seems one company developed, researched, submitted to the FDA, and marketed a system for vacuum wound therapy. Ultimately, they got their own AMA CPT codes and CMS RVU's for very lucrative reimbursement of their proprietary device. Now, it seems, some in medicine are figuring out this very expensive treatment is really no more than simple suction on the wound - something that could cost a mere fraction of what the proprietary device is currently getting.
dras
posted by nawledge at
9:52 PM
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