Importance of FDA Approval for Medical Devices
Successfully taking a medical device to market involves adopting a methodological approach. This approach includes classifying the device according to specific standards and implementing the requirements attached to that class. Determining the classification category and outlining the diverse regulations that apply to individual medical devices manufactured for commercialization is where approval by the Food and Drug Administration (FDA) comes into the picture.
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. The CDRH classifies medical devices into one of three categories. Class I devices, such as surgical scissors, are sometimes exempt from FDA approval while most Class II and III devices require premarket approval.
Manufacturers seek FDA approval to ensure a medical device meets the specified requirements that allow their sale and use within the United States and across other countries. The Mutual Recognition Agreement (MRA) reduces the duplication of inspection efforts from the FDA and other medical device regulatory bodies across the globe. Thus, FDA approvals are acceptable in a variety of countries. Gaining FDA approval comes with other benefits that will be explored in detail in the next paragraphs.
FDA approved vs. FDA cleared
Before delving into the other benefits that come with an FDA approval, it is important to note the difference between “approval” and “clearance” as they apply to medical devices. First, FDA approval means a medical device meets specified regulations and the device has been tested to determine if the benefits of its use outweigh the known risks associated with using the product. In scenarios where proposed Class II or III devices will be used for invasive purposes, FDA approval follows rigorous testing. FDA approval is mandatory when manufacturing high-risk medical devices for the US market.
FDA clearance applies to devices that are manufactured to support other devices and are used for low-risk healthcare procedures. These devices are quite similar to other devices already used within the US. Getting an FDA clearance involves submitting a premarket notification form that documents and demonstrates the device’s capabilities and its similarities with other marketed products. The FDA assesses the premarket notification applications and clears the product for public use.
The difference in the required processes can be illustrated by the real-world example of an implant (requires approval) versus a blood glucose monitor (requires clearance). Gaining approval for the implant involves extensive documentation and testing of how the relevant organs react with the proposed implant materials. If the benefits outweigh the associated risks, the implant will be approved. However, if the manufacturer intends to manufacture blood glucose monitoring devices, providing documentation comparing its device to the tens of monitoring brands already on the market can get the manufacturer an FDA clearance.
The importance of FDA approvals to the public includes their ability to highlight the safety records of a device, determining how a device will function in the real world, understanding the risks associated with a medical device, and clearing a device for use across other geographical locations.
Improving patient safety
The medical device manufacturing industry is a lucrative one. The industry is worth approximately $500 billion of annual revenue with the potential to hit the $700 billion mark by 2027. In this growing market, many new players are interested in tapping into this profitable sector as seen in the proliferation of Class I devices as exercise and monitoring tools. Ensuring that all enterprises play by the rules and safeguarding patients is the FDA’s responsibility.
FDA approval on a medical device highlights the fact that the device has gone through the rigorous, targeted testing required to prove that it is safe. Thus, the seal of an FDA approval tells the end-user that a particular device is likely to function as intended.
Understanding a medical device’s capabilities
Asides from the formal approval needed to introduce the device into the market, the testing and documentation process provides both the FDA and the manufacturer with a comprehensive understanding of the medical device’s capabilities. This comprehensive knowledge of the device ensures that there are no errors in classification, and prevents a device from being sold under false pretenses.
For medical devices that serve dual purposes, the FDA evaluates the device according to the multiple services it is intended to provide. FDA approval for such a device will specify its usage criteria to ensure the device is used within its proper limitations.
Understanding associated risks
Materials that come in contact with the human skin or organs could cause reactions that are not entirely positive or good for the health of a patient. The FDA approval process evaluates these reactions across a diverse spectrum of patients to understand potential reactions. Using the evaluation results, the FDA determines if the associated benefits are worth approving for the specified device. Understanding reaction processes and timelines also help with providing solutions to mitigate the risks associated with using approved medical devices.
Getting FDA approval for your medical devices
Without an FDA approval or clearance, taking a medical device to market is impossible. Thus, manufacturers must have a clear-cut plan on how to get their medical devices approved. Thankfully, the FDA provides an extensive list of resources that cover the classification process, documentation, testing and validation, and applying for approval. Here are some resources that can help:
- Understanding the classification process
- Guidance for documenting medical device capabilities
- Registration of medical devices
Contact an ACHB representative today for your medical devices needs.