Before we dive into the core details, can you answer one of our simple questions? Have you ever driven a car or another similar vehicle of late? If yes, then chances are high you would have enjoyed the experience, right? However, if not, you might have found some unresolved issues in the four-wheeler that was the reason for your ruined experience. For instance, the distance between the driver’s seat and the steering wheel might be too much, or the gear lever might be a bit out of your reach, resulting in slight inconvenience when you get behind the wheels. So, in the latter case, don’t you think if the manufacturer integrates some seat adjustment systems into the automobile, its driver-friendliness will increase, and more customers will put money on their product? If yes, we two are on the same wavelength! Do you know how? Well, the situation with your medical device could be the same. It doesn’t matter how advanced technologies or the features your medical machine comes with; if patients, doctors, or nurses can’t “use” it “easily,” no one would buy your equipment ever. So, to learn how to make your product more safe, efficient, and satisfying for end-users, it is necessary to know “how to get a medical device FDA approved?”
Remember, once you have optimized your healthcare equipment with the help of outsourced human factor engineers, its user experience will improve, and the possibilities for concerned patients to live longer and better will boost. Do you know how? “Well,” the main aim of leading human factor engineering service providers is to solve the greatest challenge of medical machine’s design, i.e., make it perfectly fit for human use. And it is the main reason FDA or The Food and Drug Administration has set some rules that every medical device maker must follow to ensure their offerings doesn’t harm or kill any treatment-seeker out there.
Now before you dig deeper into “how to get a medical device FDA approved?” it is essential to learn some fundamental things, such as:
What is FDA Approval?
The FDA Approval refers to the fact that the FDA has formally approved your medical appliance to be used by its target audience, like patients, nurses, medical practitioners, and caregivers. By getting this acceptance, you can rest assured that your inventory is safe and effective to use for each of them.
However, to get FDA approval readily, it is imperative to prove your device’s compliance with FDA regulations as early as possible. Now, you might want to ask:
What is FDA Compliance?
So, you can understand “FDA Compliance” as the practice to adhere to the safety regulations set by the FDA for life-saving medical machines. Getting FDA Compliance is instrumental for every healthcare equipment fabricator out there who wants to get their commodity out to market.
What is the main difference between FDA Compliant vs FDA Approved?
Here, you need to learn mainly two things:
- All FDA approved devices indicates that they are FDA compliant, but sometimes your device could be an FDA complaint still pending FDA approval.
- You can only use the term “FDA Approved” for promoting your medical equipment among your target consumers when you receive a letter from the FDA stating that your appliance got approved.
With that over, it’s time to jump directly to the topic, how to get a medical device FDA approved. So, let’s see:
A 5-Step comprehensive guide to getting a medical device FDA approved
Know your device’s classification
Just to let you know, medical devices fall into three categories:
So, you must determine the class of your medical machine before its development process starts. Bear in mind that how you will have to manage your device requirements and testing entirely depends on the class your device “belongs to.” Besides that, the category of your device will also determine the set of regulations your healthcare appliance needs to “comply with.”
Produce a prototype
Now prepare a prototype to test it in laboratory environments and reduce the possible risks before it is ready for your target users to use.
Submit your applications (If Applicable)
Now, if you want to get formal permission to market and distribute your class II or class III device, it is essential to get FDA Clearance quickly. For that, you need to submit a premarket application to the FDA. However, to “get” that, please make sure you have the FDA verification and validation for your machine.
Wait for FDA Approval
Now, you have to wait patiently for the FDA to review and approve your medical equipment.
Maintain FDA Compliance
Lastly, even if you have received FDA approval, it doesn’t mean you are in the clear. The reason? You need to make sure your device remains in compliance with the FDA regulations for the rest of its life.
Over to you
We hope you learned a “battery” of things through this write-up, be it the definition of FDA Approval, FDA Compliance, and “how to get a medical device FDA approved?” So, if you like sailing through this content and want to get excellent human factor engineering services for your medical device now, please don’t forget to make a “call” to the long-standing human engineering firm in the USA.