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Are You Selling Devices That Aren’t FDA Cleared?

Are You Selling Devices That Aren’t FDA Cleared?

In the medical field, the top priority should be the safety and effectiveness of medical devices for patients. This is why entities such as the Food and Drug Administration (FDA) exist. They play a role in overseeing the safety of these types of products.

Recently, there’s been a disturbing trend where some practitioners are purchasing and using medical devices that have not been cleared by the FDA. This practice is risky not only to patients but to the doctors’ businesses as well.

Read on for more information on devices that aren’t FDA cleared and how you can ensure you’re receiving quality products when you do decide to purchase them.


Understanding FDA Clearance

FDA clearance is not just a red-tape hurdle. It is a rigorous assessment of a medical device’s safety and efficacy. When something is FDA cleared it means that it has been subjected to extensive testing and review. This ensures that it meets the strict standards that are set by the FDA.

This type of clearance is crucial, especially for devices like Red Light Therapy units, which are used by thousands daily in the medical industry.

FDA Approved in red on a white background

FDA Clearance Process

The FDA Clearance Process is not just a stamp of approval. It takes time and a rigorous testing phase in order to get the proper clearance. The steps involved are:

  • Discovery and Concept: There are 3 different classes in this process. Class 1 poses the least amount of risk to users. Class 2 may require labeling criteria. And Class 3 devices sustain life and need more rigorous testing.
  • Preclinical Research: During this stage the devices are not used by humans. The devices are tested in a laboratory setting.
  • Beginning of Approvals: In this stage humans begin to use the prototypes to make sure they are safe.
  • FDA Review: During this part of the process the FDA reviews all data and makes a decision on whether to approve it or not.
  • Monitoring: The devices are continuously monitored for safety and effectiveness.


The Risks of Non-Cleared Devices

Some practitioners want to help their patients effectively and quickly, so they may see a deal on a website that can get their device to them in 2 or less days, and purchase them. Unfortunately, a lot of these devices that are purchased this way are directly from manufacturers in China and end up bypassing the FDA clearance process. There are several repercussions that a practice can face. They are:

  • Legal Penalties: Using non-cleared medical devices is a violation of the federal regulations set by the FDA. Practitioners could face legal actions, fines, penalties, and other criminal charges.
  • Product Seizure: The FDA has the authority to seize non-cleared devices which threaten the funds and reputation of the practitioner’s office.
  • Business Damages: The damage to a doctor’s office and reputation from using non-cleared devices can be profound. It may lead to a loss of trust from patients and eventually loss of business.
  • Health Risks: Non-certified devices have not undergone the necessary safety evaluations that the FDA conducts. This can pose serious health risks to patients which can lead to lawsuits.


The Case for FDA Cleared Devices

Does that sound like a nightmare? Luckily companies like Bedrock Bioscience exist. We only sell FDA cleared devices. They have met the safety and efficacy standards so that you can make sure your patients receive reliable and safe treatment. By choosing a company like Bedrock Bioscience, practitioners show their commitment to patient safety and that they put their patient’s health above all else.


The Benefits Far Outweigh the Risks

For healthcare providers, the choice should be straightforward. FDA cleared devices, like those you’ll find on the Bedrock Bioscience website, not only comply with FDA standards and regulations, but they also ensure that your patients receive the safest and most innovative treatments. Our commitment to using only FDA regulated products shows our dedication to your patients.

Body Reboot LED Light Pad

Don’t Get Caught By Flashy Price Tags

The trend of using non-FDA cleared Red Light Therapy devices is concerning in the medical industry. Wanting to save money is understandable but the legal, business, and health implications for non FDA devices are far too great to gamble with.

As healthcare professionals the responsibility for patient safety lies on your shoulders. It’s part of your Hippocratic Oath. By choosing FDA cleared devices you are safeguarding your patients, your practice, and your reputation.

If you have questions about Red Light Therapy, our devices, or how it all works, don’t hesitate to reach out. We look forward to hearing from you.

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