FDA Medical Device Recalls Up 97% Over Last Decade (Pt. 2)
May 30, 2014
Picking up where FDA Medical Device Recalls Up 97% Over Last Decade (Pt. 1) left off, here we will delve into some of the possible reasons as to why so many FDA medical device recalls have been issued over the past 10 or so years.
Why So Many Recalls? The FDA 510(k) Process May Be Largely to Blame…
Such a dramatic jump in the number of FDA medical device recalls issued over the past 10 years has led to much speculation as to why so many more recalls are occurring. Some of the questions people are asking include:
- Are manufacturers getting sloppier and cutting more corners with devices used to save lives or support vital functions?
- Has the FDA failed to properly evaluate these devices and, consequently, been too hasty to approve them?
In its reasoning, the FDA has explained the exponential increase in medical device recalls as being caused by enhanced awareness among medical device manufacturers and regulators themselves, namely in that these entities are catching potential problems with medical devices earlier and are issuing recalls before there are serious threats to the public.
However, this may simply be a positive spin on one of the real underlying issues associated with these recalls – specifically that many medical devices are being brought to market without sufficient clinical safety testing due to the FDA 510(k) process.
A Closer Look at the FDA 510(k) Process
According to the FDA 510(k) approval process, medical device manufacturers can seek approval for their products by citing substantial similarity to devices already approved by the FDA.
This effectively allows these manufacturers to bypass essential safety testing of these devices (in fact, this is how many of the metal-on-metal hip implants obtained FDA approval). In other words, the FDA 510(k) application process essentially creates a loophole for manufacturers, allowing them to bring potentially dangerous or defective medical devices to market faster by not having to spend the time (or money) on clinical tests to thorough evaluate the safety of their medical devices.
The FDA has yet to close this loophole, and many products liability lawsuits filed on behalf of people injured by dangerous medical devices have cited the 510(k) process as being problematic if not outright reckless.
Portland Product Liability Lawyers at the Savage Law Firm
If you or a loved one has been seriously injured due to a dangerous or defective medical device, you can count on the Portland product liability attorneys at the Savage Law Firm to advocate your rights to compensation and justice. For more than three decades, we have been dedicated to providing each of our clients with personal attention, respect and the highest quality legal services.
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