MEDICAL DEVICE AUTHORIZATION
What is Medical Device Authorization (MDA)?
Certain medical devices in the United States are regulated by the US Food and Drug Administration (FDA). These regulated medical devices are usually ones that require specilized training and/or licensing to purchase and safely use. A medical device is used to help diagnose, prevent, or treat a patient usually without the use of chemicals or drugs.
There are 3 classes of medical devices:
- CLASS I (low-risk devices): These devices are indentified as presenting the lowest risk to patients out of the FDA regulated devices. Some CLASS I medical devices require MDA but most do not. The majority of first aid items and devices fall under this classification. Some examples of CLASS I devices include: bandages, tourniquets, NPA, and trauma dressings.
- CLASS II (moderate-risk devices): These medical devices generally require more advanced and specialized training to use. These devices are identified as presenting a moderate or intermidiate risk to patients and require carefull attention to specific techniques for safe use. Most CLASS II medical devices require MDA before purchase. Some Examples of CLASS II devices include: BVM, decompression needle, saline lock/IV kits, and hemostatic gauze.
- CLASS III (high-risk devices): These medical devices are highly specialized and are often vital to sustaining patient health and/or life. CLASS III devices typically require MDA before purchase as they are more complex and have special controls in place to ensure their safe and effective use. Some examples of CLASS III devices include: pacemakers, artificial heart valvues, deep-brain stimulators, and some types of orthopedic implants.
Medical Device Authorization is given to those who have been properally trained and are licensed for such a purchase. Medical Device Authorization is based on the specifc product being purchased.
Who is responsible for Medical Device Authorization (MDA)?
Medical Device Authorization is the sole responsibility of the customer / purchaser.
By purchasing regualted medical devices from Dynamic Defense Solutions the purchaser certifies and confirms that they are properly trained and appropriately licensed to make such a purchase. The purchaser also assumes all responsibility surrounding the use of products that require Medical Device Authorization and is responsible for the appropiate and safe use of said product.
MDA EXAMPLES:
Purchasing products from Dynamic Defense Solutions that require Medical Device Authorization certify that you are:
1. You are properly trained and individually licensed to purchase said products.
2. You are operating under the supervision, direction, and guidlines of a licensed individual or entity.
3. You are a purchasing representative operating on behalf of an authorized / licensed entity.
What products require Medical Device Authorization (MDA)?
All products sold by Dynamic Defense Solutions that require MDA will be indentified and marked acordingly.
All regulated items requiring MDA are marked just above the product description with a red outlined text field/link that says:
"This product requires Medical Device Authorization". Additionally on all MDA products, there is a "yes / no" selection that must be made prior to adding the product to the cart for checkout.
Some IFAKs, and other kits may include medical items that require Medical Device Authorization. These products will be marked the same way and may offer options that are available for those without MDA.
Seek the appropriate training
Being properly trained to have the knowledge and skills to use medical devices is vital. We strongly encourage you to seek professional training and education when it comes to medical skills and the use of specific medical devices.
If you are interested in the different medical training and educational programs Dynamic Defense Solutions has to offer, please visit our medical training page:
US Food and Drug Administration (FDA) rules & regulations