Grace Cuillier from Proxima Clinical Research outlines the key differences and benefits of each FDA designation to equip you with the knowledge you need to steer your product along the most efficient pathway!
Can't watch right now and rather read a quick summary? Here is a recap of what Grace shares in the video:
Hello. Grace here from the team at Proxima Clinical Research.
This video will be discussing the differences between five similar sounding but very different FDA statuses: FDA Registered, FDA Cleared, FDA Granted, FDA Authorized and FDA Approved.
Let's start with FDA Registered.
- FDA Registered is when a company registers with the FDA and provides basic information about their establishment, such as their address and contact details. Companies also register any products they develop in a process known as listing. However, it's important to note that FDA registration does not imply any approval or clearance of their products. It's simply a regulatory requirement for businesses that produce regulated medical products in the medical and biotech industries.
- Next, we have FDA Cleared. This term is used for medical devices that have gone through the premarket notification process, also known as a 510(k). This process is typically used for moderate risk medical devices that are similar to products already on the market. If the FDA determines that a given device is substantially equivalent in terms of safety and effectiveness to a predicate device, the product receives 510(k) clearance and can be marketed and sold in the US.
- FDA Granted is a newer term referring to novel Class I or Class II medical devices that have no legally marketed predicate device. These devices submit a De Novo classification request, and if the benefits of the device outweigh the risks, then FDA will grant the device marketing authorization.
- FDA Authorized is a term that refers to a medical product that is made available via an emergency use authorization or an EUA during a public health emergency. Most notably, several products utilize this pathway during the COVID 19 pandemic, such as vaccines, ventilators and diagnostics. An EUA allows these products to be used during a public health emergency without full FDA approval, but they must meet eligibility criteria and provide information in support of their safety and efficacy.
- Finally, we have FDA Approved. This rigorous designation is reserved for devices that require a premarket approval or PMA and Humanitarian Device Exemption or HDE. In addition, drugs and biologics also receive approval by the FDA. These products have gone through rigorous testing and clinical trials to demonstrate their safety and effectiveness. FDA approval signifies that the product has met the FDA's strict standards and can be marketed and sold in the U.S.
Understanding the nuances between these FDA statuses and their prerequisites will certainly have an impact on your journey for product approval. This is why allying yourself with an experienced CRO like Proxima is your best chance for success.
See the difference we can make by visiting us at proximacro.com