GAINING REGULATORY APPROVAL

In reviewing medical devices, the FDA cares primarily about two things: Safety and Efficacy

In order for a company to market a medical device in the United States, it is necessary that they gain approval from the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. Ensuring FDA approval requires evidence that the device was designed and manufactured under a quality system conforming to US Code of Federal Regulations 21 CFR part 820. Conforming to these standards is not optional – it is illegal to sell medical devices that have not been approved by the FDA. Although the FDA approval process can be tedious, starting with a good quality management system and understanding what the FDA is looking for can help streamline the process and make sure the device ends up getting approved.

Quality Management Standard

Subscribing to a recognized quality management system makes the FDA approval process go much smoother, and helps companies make sure they conform to FDA standards. ISO 13485 is a quality management standard specific to the medical device industry, and is recognized worldwide. Although being ISO 13485 certified does not guarantee approval by the FDA, the standards are so similar that ISO 13485 certified companies are more likely to get their devices approved.

Getting an ISO 13485 certification is a valuable first step in getting approval for the product, and it also helps make sure the device will meet international standards. An ISO 13485 certification demonstrates that a company has a quality management system that complies with the requirements of the FDA, and greatly increases the chances of submitting a complete package to the FDA or international regulatory bodies. It serves as an effective risk management strategy that increases the chances of creating successful products and helps prevent recalls, safety issues, or brand damage.

Submission Guidelines

The first step to successfully getting a device FDA-approved is to understand the FDA submission guidelines. Different types of devices are subject to different types of regulatory policy, so understanding how the FDA classifies devices is important to making sure the product gets approved. The categories are determined by how risky the device is to the user, with riskier products requiring more comprehensive testing.

Class I medical devices, for example elastic bandages or manual stethoscopes, involve little risk to the patient, and only need to be registered with the FDA, rather than approved. Class II medical devices, which include products such as powered wheelchairs or x-ray machines, are more complex and have the potential to pose some risk to the patient, and therefore more information and testing is required to get them certified.

Class II devices require the submission of a 510(k). Class III devices have the potential to pose the most risk to the patient and often play a life-supporting or life-sustaining role, for example pacemakers or breast implants. A device can also be Class III if it is not similar to anything else on the market.

Since Class III devices pose the highest risk, they also require the highest quality assurance, and usually require a premarket approval (PMA). There are some alternative paths to gaining FDA approval, such as using the de novo classification, but generally FDA approval involves either a 510(k) or PMA. Understanding the device’s classification and the information and documentation required by that classification is a key part of getting the FDA to approve the device.

Safety and Efficacy

When reviewing medical devices for approval, the FDA cares primarily about two things: safety and efficacy. Safety is the biggest factor when seeking approval for a medical device, and the more potential risk the device has, the more testing and trials it will have to undergo before it is approved. Risk management is a key part of the process to FDA approval, because obviously a device that is not safe for consumers to use cannot be allowed to go to market. The FDA also requires a design history file (DHF) containing evidence that a compliant quality system was followed to get cleared or approved. Designing medical devices is not just about whether the end design works safely; it’s also about following a compliant process along the way and documenting the process steps as evidence to conformance.

The FDA also wants to determine whether the device is “effective,” essentially whether or not it successfully does what it is supposed to do. The FDA requires documentation demonstrating that the device meets the claims published about the device (in the device “labeling”). The more ambitious the claims about the device, the more extensive the clinical or simulated testing that is required for approval. Ensuring that the device conforms to both safety and efficacy standards helps the device move smoothly through the FDA approval process and get to the point where it can be marketed.

The ‘CE’ Mark

If a company plans to market a device in Europe as well as in the US, a slightly different EU standard must also be met in addition to the standards set out by the FDA. The company must demonstrate that the device meets the requirements in the Medical Device Directive (MDD) by performing a conformity assessment. This assessment varies according to the classification of the device.

This then leads to the device receiving a CE Mark, which is a manufacturer’s declaration that the product complies with the ‘essential requirements’ of the relevant European health, safety, and environmental protection legislation. Although the requirements for receiving FDA approval and a CE mark tend to be very similar, as the CE mark focuses around safety and efficacy as well, they are two different systems and the documentation needs to be submitted separately. Some devices end up with only one or the other.

Conclusion

Seeking FDA approval can be something that is very overwhelming for medical device companies, especially if it a process they have not necessarily gone through before. However, in order to bring a device to market it is absolutely imperative that it goes through the FDA approval process. Although the process is difficult, there are a few things to help make it easier – having a good understanding of how the FDA classification system works can help ensure that companies have completed the right testing and documentation, and focusing on making sure the device is proven to be efficient and safe will go a long way in helping to streamline the process. Additionally, although the CE mark is not the first priority for a company looking to get FDA approval, it is something important to keep in mind to make the process more efficient.