August 15, 2018

A Client’s Journey to FDA Clearance

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Phoenix-based (and Framework client) TAMA Research recently received notice that its BlueOnyx™ Gen II received 510(k) clearance from the FDA. We couldn’t be more thrilled. Not only for the validation of the safety of the product but also what it means from a business perspective. I've tried it and I'm a big, big fan.

What is BlueOnyx™ Gen II?

It’s a microcurrent skin treatment medical device that delivers electromagnetic waves to target a multitude of skin issues, like loss of elasticity, wrinkles, inflammation, acne, and more. It is sold to dermatologists and aestheticians that are then given ongoing training by TAMA Research.  

Obtaining FDA clearance is no small feat. In 2017 alone, more than 15,000 products were submitted for review, and only 2,957 were cleared. All devices and equipment used in a medical setting require FDA review and clearance before being marketed in the U.S. According to the FDA, medical devices and technology encompass any instrument or product used for treating or diagnosing disease.

We sat down with Tina Abnoosi, President and CEO of TAMA Research, to learn more about the FDA review process and what it means to the company.

How does the device work?

Using our proprietary and patented wave technology (a patent that is named for our chief technology officer), the BlueOnyx™ allows dermatologists and aestheticians to utilize noninvasive microcurrent technology to bring about remarkable results for their patients and clients, respectively, with skin problems.

What’s the difference between clearance and approval?

While the term FDA-approved is widely used, technically, the FDA does not “approve” devices; they clear them for sale in the US.

Why was it important for you to get FDA clearance?

First and foremost we wanted to ensure the device is safe for both the patient/customer and for the individual administering treatment. I am an electrical engineer with 25+ years of experience designing and manufacturing electromagnetic components for diverse industries. My partner, Ali Shambayati, who has a master’s degree in biomedical engineering and a bachelor’s in electrical engineering, has worked as an engineer for 30 years. We are process people who rely on science and proof. It was essential that our product be submitted to the rigors of the FDA clearance process, not just because it’s good for business but also because it’s important to us as professionals who respect the importance of oversight. FDA clearance legitimizes and validates the seriousness of your product and, in fact, your entire enterprise.

What was the FDA process like?

The process was lengthy and comprehensive. I liken it to applying for and receiving your green card. It’s laborious. It took two years for us to prepare everything for submission and 20 submitted packets of information. We hired six consultants, including Framework Legal, to get us to the finish line. It took about 3.5 months after the review process to hear back that we’d received clearance. It’s understandable that many companies don’t want to go through this process. And many don’t which puts them in a very vulnerable position if they get caught by the FDA. It also puts their clients at risk. This simply wasn’t an option for us.

Was there anything about the process that surprised you?

The FDA engineers do their due diligence, and then some. They knew our technology, design and the labs that do our testing almost as well as we do. Their depth of knowledge floored me. I have a great deal of respect for the FDA and its staff.

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