FDA Approval Process for Medical Devices: Step-by-Step Guide

How are medical devices regulated in the USA?

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:

• Class I with exceptions – low-risk products that do not need to have a quality management system or meet certain regulatory requirements.
• Class I without exceptions – low-risk medical devices need to meet all applicable requirements and have a quality management system.
• Medical devices Class II – devices with special controls for “labelling, guidance, tracking, plan, performance standards, and post-market observation”.
• Class III devices with/without premarket approval – products that continue or support human life, are embedded, or present a significant risk of illness or injury.

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.

What are the steps in the FDA approval process?

1. Identify a predicate device for comparison and create a comparison chart.
2. Determine your device’s correct risk class and whether it falls under the FDA 510(k) pathway.
3. Identify the appropriate 7-digit regulation number and three-letter product code of your medical device.
4. Determine all applicable requirements and standards.
5. Gather all relevant FDA guidance documents from the FDA website.
6. Find out if clinical data is required, and if so, perform clinical studies.
7. Determine if performance testing is required, and if so, perform the necessary tests.
8. Assemble a 510(k)-documentation application.
9. Pay the relevant fee for 510(k) application review and submit your 510(k) documentation to the FDA
10. Receive confirmation from FDA that your 510(k) documentation was accepted for substantive review.
11. Receive a clearance letter from the FDA confirming that your medical device can be legally marketed in the USA. You will not receive a compliance certificate.

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:

• Receive a “Pre-Submission (Pre-Sub)” input from the FDA.
• If a clinical examination is necessary, you must apply for an Investigational Device Exemption (IDE). You need to develop a clinical trial agreement and conduct clinical studies.
• Pay the relevant fee for PMA application submission and submit your application to the FDA.
• The FDA will have to perform a facility investigation of every major supplier associated with your device’s design and production. All parties will need to be consistent with the FDA Quality System Regulation (QSR).
• Receive a PMA approval letter confirming that your medical device can be legally marketed in the USA.

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.

What do you need to do if your device is truly innovative?

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.

How long does it take to finalize the FDA approval process for medical devices?

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.

How can we help?

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:

1. Perform a proper regulatory GAP analysis to determine a suitable predicate device, correct classification and all the applies to their products.
2. Create a complete FDA 510 (k) premarket notification application, containing all the documentation FDA will need.
3. Register with the FDA
4. Perform Q-submission or De Novo classification
5. Provide PMA assistance for class II and III devices.

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.

Relevant links:

• Medical device classification under the MDR 2017/745
• Guide on CE marking medical device software
• Regulatory GAP analysis for medical products
• Medical device technical file for compliance with the MDR 2017/745
• MDR labelling requirements for medical devices
• SCIP compliance for European manufacturers