This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
In the United States, all medical devices’ safety and effectiveness are regulated by the Food and Drug Administration (FDA). The regulatory pathways for medical devices – 510(k) clearance and PMA (Pre-Market Approval) – are built on the following risk classifications:
Most Class I medical devices can be self-enrolled, but a large amount of Class II devices require a 510(k) premarket notification submission. And for Class III medical devices, a PMA submission is often required.
Manufacturers must follow Current Good Manufacturing Practice (CGMP) regulations when developing their medical devices. The FDA examiners use the CGMP regulations to decide whether a manufacturer has the facilities and know-how to deliver and pack their product. Additionally, all medical devices must have a unique device identifier (UDI) that is understandable by both machines and humans.
Here is a complete overview of the FDA certification process for medical devices:
You should note that if your medical device does not have a predicate device, the FDA 510(k) pathway described above will not apply. In such a case, you will need to obtain an FDA premarket approval (PMA), including the following:
Lastly, if your company is not located in the USA and has no local presence in the country, you need to name an FDA US Agent representative as your local point of contact with the FDA. List your medical device and register your company utilizing FDA’s FURLS framework as per 21 CFR Part 807. Pay all yearly charges for Establishment Registration and Listing and start to market your product in the US.
If you have truly innovative technology or your medical device combines two already-existing technologies, you should ask FDA for their opinion on the correct risk classification and relevant regulatory requirements by submitting a 513(g) request for information.
Manufacturers of innovative low-risk medical devices without an appropriate predicate device can go through the De Novo classification process, allowing FDA to assign a Class I or Class II designation and respective product code/regulation number to their products. An alternative is to request a Q-Submission meeting (Q-Sub) with an FDA representative to clarify the applicable regulatory requirements and discuss the clinical studies needed to support your submission.
The FDA has 90 days to audit your 510(k) application after you submit it. During the audit, they will likely reach out to you for additional product information, at which time the “90-day clock” is stopped and restarted upon the FDA’s receipt of the requested information.
If your medical device is cleared, you will receive a clearance letter mailed to you. The letter will also be published on the FDA’s website so that all your clients know that you are presently cleared to sell your device. The letter will indicate that the product is comparable to the identified predicate device stated in your 510(k) application, and you may begin to market your product in the US. You should note that the FDA will not provide you with a certificate.
Clever Compliance is a Swedish company, known for developing groundbreaking cloud-based compliance solutions, such as our supplier compliance software and compliance management system, and providing reliable certification services to various economic operators.
We at Clever Compliance make sure that manufacturers go through the FDA approval process for medical devices problem-free and get clearance for their products as soon as possible. We help our clients:
Additionally, we also assist companies with obtaining CE marking approval for medical devices of any risk class. Get in touch with us at [email protected] to learn more about our work process and how we can assist you.