If you are a Georgia resident who has been harmed by a defective medical device, contact us immediately
The FDA is required to approve medical devices before they can be implemented by healthcare professionals and hospitals. This can be accomplished by either premarket approval or 510(k) approval.
For PMA approval, the creator of the medical device must present an extensive application explaining the design and trial results of the device. The PMA approval process balances the benefits of the device against the risks of implementing it. Then, the medical device’s manufacturer must be in compliance with the PMA-approved design, promotion, and production process.
By contrast, a 510(k) approval simply requires the manufacturer to prove that the medical device has already been cleared by a different manufacturer and is basically the same device. Further, a 510(k) approval requires no regulatory FDA approval prior to use by physicians. If the FDA attempts to put marketing limits in place, the device manufacturers can get around this by deceiving physicians or recruiting them as ‘specialists’ to promote off-label use.
Clearly, PMA approval offers more protection than a 510(k) clearance does. The Law Offices of Robert A, Rivers has taken-on medical device manufacturers with both PMA and 501(k) approvals — and won. During investigative research we have also discovered kick-back conspiracies in which healthcare providers are compensated for using certain medical devices. The patients, of course, know nothing about this money-making scheme which oftentimes conflicts with the patient’s best interest.
Medical device lawsuits can be involved and are ever-changing, as the laws concerning them vary from state to state. If you are a Georgia resident who has been harmed by a defective medical device, contact us immediately — before the two-year statute of limitations runs out.
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