FDA “Cleared” Versus “Approved”: What’s the Difference?

FDA “Cleared” Versus “Approved”: What’s the Difference?

The question is sometimes asked, why is Alpha-Stim “cleared” by the Food and Drug Administration (FDA), as opposed to “approved?” Of course, all the medical devices in the U.S. market are examined by FDA to determine if they are safe and effective.

All manufacturers who seek to market medical devices in the United States must first pass a very thorough process with the FDA through one of two pathways—the section 510(k) process, where a device is “cleared” for distribution, or the Premarket Approval (PMA) process, where a device is “approved” by the FDA.

Today’s process stems from the Medical Device Amendments added to the Food, Drug and Cosmetic Act in 1976, establishing three regulatory classes for medical devices. Because there were devices already on the market prior to 1976, all devices were considered either pre-amendment medical devices, or new concept medical devices that had never been in commercial distribution (e.g., MRI, and lasers). The new devices had to undergo a PMA, a process that is significantly more expensive and difficult for the manufacturer, more like a new drug application ending in FDA “approval” due to the fact that there is no existing history of the medical device.

In order to accommodate the pre-amendment devices, the FD&C included a clause in section 510(k), which states that if a medical device manufacturer can prove their technology is “substantially equivalent” to a type of medical device that was on the market prior to 1976, then the FDA can clear the device for commercial distribution using the slightly easier requirements of the section 510(k) process.

Alpha-Stim® has gone through the section 510(k) process, and as a result is FDA cleared for interstate marketing and export for the treatment of anxiety, insomnia, depression and acute, post-traumatic and chronic pain.

In its attempts to correctly classify the Alpha-Stim, Electromedical Products International has presented several “mini-PMAs” to the FDA over the years, along with a full PMA on anxiety in 1995. As a result, Alpha-Stim has endured more FDA regulatory requirements than most medical devices in U.S. history, including more than a half dozen extensive reviews of the safety and effectiveness of the technology along with post marketing surveillance, and biannual quality system reviews.

In the end, FDA does not endorse any medical product, be it drug or device, and regardless of how a product enters the market, both FDA approval and FDA clearance are legally equal authorizations to market and export a device.

The Alpha-Stim AID utilizes cranial electrotherapy stimulation (CES) to deliver the only rigorously tested and patented waveform that is clinically proven to treat anxiety, insomnia, and depression. The Alpha-Stim M uses CES to treat mood and sleep disorders, plus microcurrent electrical therapy (MET) to also treat pain.

Alpha-Stim® has been on the market as a pain and mental health solution for over 35 years and has more research than any other therapeutic MET or CES device. There are over 100 studies published to date and over 20 currently underway. Our research is so good even our competitors use it! FDA accepts a broad range of waveform parameters for the CES category, which is not unusual. For example, both aspirin and morphine are categorized as analgesics but we all understand the considerable differences between the two. Only Alpha-Stim® is proven to get the results shown in Alpha-Stim® research.

Click here to see the Alpha-Stim® Clinical Examination Report prepared in accordance with the European Medical Device Directives. This report contains a description of Alpha-Stim technology, the history of cranial electrotherapy stimulation (CES), mechanisms of Alpha-Stim based on fMRI, LORETA and qEEG studies, along with graphic summaries and annotated abstracts of all our research including many double-blind, placebo (sham) controlled studies including some with crossovers, open clinical trials and well-constructed scientific surveys. These studies, all conducted by independent investigators, mainly at universities or government hospitals, almost always on drug resistant patients, has consistently revealed significant p values to p<.001, and medium to large effect sizes.

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