Apr 28 2022
In the medical device industry, time is the most important thing to your device market in the United States after innovation.
We can't exactly know how long the process will take until FDA approves your medical device, knowing the basics of the FDA approval process and timeline can help you have a better plan for your device and be proactive for the next process.
Then, How long the process will take until your device get approval from the FDA?
It will take from a week to 8 month and it depends on the device classification and various factors.
Understanding the FDA approval time of your device, Let's look for the basics of those processes with three classifications.
Class I : Affecting patients and regulatory requirements have the least impact.
Class II : It is for the device which has a middle-risk between class I and class II.
Class III : It requires a high standard managing and mostly needs PMA(Pre-market approval)
Class I Device
You can register with FDA and It takes only a week or 2 weeks for approval.
Class II Device
The best time for your device to market is 6month, but some devices may have approval in 3month.
Class III Device
FDA focus on those devices compare to self-registration and 510(k), this process is shortened to an average of 8month.
This, as well as there, are two pathways to determine when you market your device in the United States.
If your company is in the early stage of developing your device similar to the existing device in the market, it will be your route for 510(k)-Premarket notification. In the guidance of the FDA, It requires you to submit at least 90 days before you market your device.
You have to prove and explain all the details when you submit a 510(k) such as how your device is different from the previous device in the market and maintain the same quality of safety and efficiency.
And also, If your company is filing a 510(k) for your device that changed significantly, It may be required the clinical trial results.
It is also required to submit Documented laboratory testing, but human data is not required for this route.
However, if you are filing a 510(k) for a device that has changed significantly, you may be required to submit clinical trial results.
FDA will determine it and notify your device.
FDA will conduct an approval and review of your 510(k) submission and will respond with the acceptance review result as below within 15 days.
the 510(k) was accepted for substantive review
the 510(k) was not accepted for review (i.e., considered refused to accept or RTA)
the 510(k) is under substantive review because FDA did not complete the acceptance review within 15 calendar days.
Another important matter to remember that is you cannot advertise as “FDA approved” even if your 510(k) submission is approved.
If your device is either completely new to the market or high-risk of the Class III device, your company is on the right path. It requires extensive scientific evidence either it's not enough the exit test to prove the safety and efficiency of your device or it's considered a high-risk device.
If there are insufficient existing studies to prove the safety and efficacy of a device, or if it is considered a high-risk device, the FDA will require extensive scientific evidence to determine if it is ready for market. It usually includes both laboratory testing and clinical trial result.
Before submitting a PMA, it is important to prepare well for the predicted documentation requirements throughout the process, including a detailed study plan about the clinical trial.
And It is important to know that whenever FDA has the right to accept, reject or request for adding the data in this process.
To minimize the review process before FDA approves your device, there are two things that you keep in mind.
1. Communication with the FDA agency like e-mail and warning letters for the FDA review process should be timely.
2. Even if you provide additional information upon request, do not assume that FDA will not request additional information (AI).
All the information required for the approval must be submitted as soon as possible. FDA will not review them until receiving the documentation fully that requires, which will add approval process time for your device. After submitting an AI request, FDA issues SE or NSE letter for the PMA submission.
As we mentioned earlier, the CDC must receive your response within 180 calendar days from the AI request. Otherwise, your submission will be withdrawn and deleted. Extensions beyond 180 days will not be accepted. Thus, to minimize those processing time for the FDA to approve your device, do not exceed 180 days is primary
In most cases, FDA expects you to respond in a same-day or next-day for the 90-day goal of the 510(k) review.
It leads your approval process time to be shortened if you follow the below instructions.
1. Prepare early in the development stage.
Make sure you understand the FDA in the development process of your device.
It is important to determine which approval pathway will be an appropriate time, cost, and resource in your approval process.
2. Relationship with FDA
Rather than concerning and thinking of the complexity and extensivity of the FDA regulation, you need to be ready with FDA as your partner that whom you should cooperate. Its purpose is to ensure the safety and efficiency of your device and provide innovative products quickly for the patients and users.
Build a relationship with FDA cooperatively in the early and developing stage for your device.
3. Submitting the comprehensive submission
Regardless of the classification of the device, focus on the demonstrating SE or safety and efficacy. And also, take time to complete the submission and check all the requirements.
4. Get help with "prototype"
Cooperate with "prototype" development expert of the safety device who provides all risk factors that considered and ensure standard compliance.
Choosing the right pathway is lead your product to be market fast and efficient.
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