The United States Food and Drug Administration (FDA) assigns specific categories to each medical device. Two of these classifications are FDA cleared and FDA approved. There is an industry need to understand these terminologies because incorrect use can lead to serious legal and regulatory consequences.
What is the difference between FDA Cleared and Approved?
A medical device is considered FDA cleared if it undergoes 510(k) submission. This clearance is given after FDA review. This review ensures that the product is substantially equivalent to other medical devices that are legally marketed, as wella s safe and effective. These FDA “Cleared” products are called predicate.
Class III medical devices need to undergo strict review and approval procedures since they are marketed legally. After a successful submission for PMA (premarket approval) or HDE Humanitarian Device Exemption, the device is approved by FDA. FDA approves a product if its benefits outweigh its risks.
Meanwhile, FDA doesn’t provide approval to Class II and Class I medical devices, only clearance. Thus, these products come with lower risk. Moreover, FDA also doesn’t approve compounded drugs, cosmetics, dietary supplements, and medical foods.
Why using the right regulatory Classification is important?
The impression of 510 (k) is among the usual routes to get a product in the market. Many medical device companies use this pathway to prove substantial equivalence with their product.
FDA reviews the provided information of a company to “clear” their devices. On the other hand, the PMA procedure, which involves Class II devices, is stricter than the 510 (k) procedure. The products need to be proven effective and safe through clinical evidence. So, FDA can place their “approval” stamp on the medical device.
Class II and Class III products undergo different FDA inspections. The inspectors are detail-oriented and closely test the company’s documentation to ensure that the terminology to be provided is correct.
Using the correct regulatory terminology is essential to avoid legal ramifications. In addition, FDA terminologies should be appropriately used since consumers search for medical devices on the internet. Thus, their purchasing decisions can be affected by the terminology used in a specific device.
Healthcare personnel is required to offer a compelling case that the product is safe to use for the patients and accurately marketed. A terminology mistake can be detrimental to companies’ marketing campaigns. With this, FDA mandates companies to use the correct terminologies for their products to ensure that the products come with excellent quality.
FDA terminologies, including FDA cleared and FDA approved, are essential to medical devices. Improper use of these regulatory terminologies can make serious legal ramifications to companies which may even lead to losing market share.
Furthermore, launching a medical product is a huge investment for a company. So, it should use the proper terminology to avoid potential problems. But, more importantly, consumers can make sure that they are using safe and effective medical devices.
In other words, proper use of FDA terminologies is essential for the safety of consumers. It also helps maintain a company’s good reputation since they adhere to the standards of the FDA.