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Getting Smarter on FDA Approval, FDA Clearance, and Wellness Products

Getting Smarter on FDA Approval, FDA Clearance, and Wellness Products

Author
Jackie Powell
Medically reviewed and approved by
Dr. Michael Sprintz, DO, DFASAM
March 21, 2024
Couple enjoying time with child
Quick Take
Getting Smarter on FDA Approval, FDA Clearance, and Wellness Products
Getting Smarter on FDA Approval, FDA Clearance, and Wellness Products
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Overview

At Spark Biomedical, we get asked a lot of questions about wearable neurostimulation. We also hear this one, “Why FDA-cleared and not FDA-approved? Is that some scam or trick?” You may be wondering the same.

We think it’s an important question and one that may have a big impact on your healthcare choices. Today, we’ll clear up some confusion about the terms FDA-approved, FDA-cleared, and wellness products. We’ll answer what these terms really mean and why you should care.

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The FDA's Big Role

At the highest level, FDA-approved and FDA-cleared products are similar in that they require comprehensive quality, safety, and efficacy checkpoints reviewed by the Food and Drug Administration (FDA) before being available for purchase. And then, there are wellness products, which are a whole different story. Let's dive in and see what sets them all apart.

The FDA is like a watchdog responsible for protecting the U.S. public health. They keep an eye on things like:

  • Human and veterinary drugs
  • Biological products
  • Medical devices
  • Our nation's food supply
  • Cosmetics
  • Products that emit radiation

Ultimately, the FDA ensures these items are safe for us to use and as effective as the manufacturers say they are.

FDA Approval: The Tough Test for Riskiest Treatments

FDA Approved Stamp

FDA approval is required for a specific group of medical products that are proven to be effective but also possess a high level of safety risk. This includes products such as: new medications or Class III medical devices like mechanical heart valves and implantable infusion pumps. These products carry the greatest potential health risk if something were to go wrong, so they require both a premarket approval application and FDA approval before being sold to physicians or patients.

To get this kind of approval, products undergo thorough scrutiny and testing, including multiple rounds of animal studies and human clinical trials to prove to the FDA that they are safe and effective and that the benefits outweigh any known risks. Because there are so many clinical studies and rounds of review before the FDA review and approval process, these products can take manufacturers several years (think 10) to develop from beginning to end.

FDA Clearance: Quicker Timeline, But Still Strict Testing for Less Risky Products

Next, there's FDA clearance. This is for less risky medical products called Class II devices. They include wearable devices, monitoring devices, catheters, or dialysis equipment. These products still need to prove they're safe and effective, and some still have to pass special controls, which may include specific testing or labeling requirements. From the time a manufacturer develops the medical device, runs a controlled clinical trial, and submits the product to the FDA for review, it can take 3-7 years for the product to be on-market.

Regardless of which path — FDA-approved or FDA-cleared, the FDA will continue to monitor safety, effectiveness, and quality for years after the initial approval or clearance date.

Wellness Products: Not in the Same League

Wellness products are things like fitness trackers or vitamins. They're more about keeping you well rather than treating a medical condition. Unlike medical devices, the FDA doesn't check these items for safety and effectiveness before they can be sold to you. So, while they can be helpful, they aren't held to the same strict standards. That means it’s up to you to do more research when looking into the safety and effectiveness of wellness products. And it’s up to you to report to the FDA should things go wrong.

Why FDA-cleared is Important

Although the path through the FDA may seem less strict, when you pick an FDA-cleared device, you're choosing something that's been tested and is safe to use. That's a big deal when it comes to your health.

That brings us to Sparrow Ascent, Spark Biomedical’s Class II device designed to treat opioid withdrawal, and yes, it's FDA-cleared. As part of FDA clearance, Sparrow Ascent passed a full set of strict safety checks, including biocompatibility and electroimmunity, while following rigorous FDA design controls — making Sparrow Ascent a solid choice for people looking for a safe, comfortable, drug-free opioid treatment option.

Ready to Take Control of Your Health?

Understanding these terms – FDA approval, FDA clearance, and wellness products – helps you make smarter choices about your health and treatments. With Sparrow Ascent, you've got a trusted, FDA-cleared option to consider in your fight against opioid withdrawal.

Thinking about giving it a try? See if you qualify for Sparrow Ascent and start your journey towards a healthier you.