510K Clearance Process

Let 510k FDA Consulting pull the missing pieces together.

We have a proven track record of clearing medical devices; it’s time for you to take advantage of our skills and the benefits of our services. Contact Lee@510kFDA.com and the process will begin.

Top 10 List for Getting Started with your 510k

Determined the need for Premarket Submission 510k.
Client signs 510k FDA Consulting Contract.
Assist Client with Application for Small Business Certification, if applicable.
Client will receive a Checklist of the information/data needed for the 510k submission.
Consultant will evaluate the new medical device and determine the product code, regulation

number, classification and predicate device to be used for the submission.

Client will send files of documents to 510k FDA Consulting for the preparation and writing.
All 21 sections of the submission will be completed and formatted per FDA regulations by the

consultant.

Submission will be sent to FDA.
FDA completes a preliminary review and then submission moves into the substantive review

and the FDA clock begins.

510k FDA Consulting follows through the process with the FDA reviewer to complete and obtain

clearance of the new medical device.

Protecting Your Trade Secret Information

We have some clients that are reluctant to offer us any information regarding their device due to trade secret information. We deal with this type of information on a daily basis and we understand to protect your information. We cannot do the research and preparation without your device information. Therefore, we have a simple Non-Disclosure form that you can print off, fill in your name and device name and sign. Send that to us and we will sign it and now you know that we are protecting this information for you. We want you to know that we understand that we are working for you and with you on this project.

Non-Disclosure Form

FDA Approval Process Of New Medical Devices

Any and all medical devices, medical products, medical instruments, and medical equipment that are legally bought and sold in the US are regulated by the FDA.

If interested in selling your new medical device in the US, you should know that they allow four different broad pathways for individuals and companies to develop, manufacture, or distribute these products in the USA. The FDA currently breaks these classification categories down by how safe and effective the actual product or device is considering it’s purpose and use-

FDA 510K Classifications

Class I - This classification is for products that are not harmful and are low risk to the general population. These types of products typically do not require strict FDA 510k review process. These types of medical devices and products can almost immediately be marketed upon FDA approval but must comply with any and all other guidelines set forth by the FDA.

Class II - This classification is for companies that manufacture or import medical devices that are considered to be more harmful than Class I products and devices. These types of products and devices are created to be extremely similar to other already legally marketed products. These types of products and devices will require you to submit a 510k “Pre-market Notification” to get your new product or device FDA 510k clearance approved.

Class III - This classification is for companies that develop, manufacture, distribute, and/or import medical products and devices that are new to any market. This class is defined as the most riskiest one out of all FDA 510k classes. These products and devices are all brand new to the market, are usually intended for new purposes and procedures, and all of these new products have to go through the FDA 510k Pre- market Approval process. This classification is the most expensive, most time consuming, and most difficult to receive an FDA 510k clearance.

Automatic Class III - This classification is for companies that are interested in bringing their new medical devices and products to the US market without their being another similar FDA approved product or device on the market to compare to. These companies that are introducing new devices and products to the market will have to file a FDA 510k De Novo petition.

FDA 510k Medical Device Approval Process-

The FDA 510k approval process adheres to most Class II medical devices and products, along with a small number Class I and Class III products or devices. After a new medical product or device has received the FDA 510k approval, then the device or product is issued a FDA 510k registration number. This special number never expires and will always be tied to the medical device or product. Bear in mind that you still need to take care of the annual Establishment Registration Fee along with keeping your devices, products, and/or manufacturing facilities in full FDA compliance to be able to legally continue to sell your medical device or products with in the United States. Be advised, once your product is FDA approved you are subject to surprise compliance inspections by the FDA compliance department at any time. SEE FDA Quality System Regulation (21 CFR Part 820) for more information on compliance and inspections.

FDA 510k Application Process

1- Research- Conduct your due diligence on other similar medical devices that already have a FDA 510k Clearance. A.K.A-“Predicate Devices.” Go to the FDA Website and search the Product Classification Database page, find and record information and registration numbers on any similar related predicate devices.

2- Review Product Classification Codes of predicate Products- After reviewing and documenting any predicate devices or products that are related to yours, research a little more into the actual Product Classification code to see if any additional documentation, testing, or other requirements need to be met before you even begin the FDA 510k clearance process.

3- Consolidate Information and FDA 510 K Application Data- Collect and review all of your own device or product information, documentation, testing data, predicate device credentials, and actual application/petition. Send off the entire FDA 510k package to the FDA mail center. Be advised there is a Device registration fee upon successful FDA 510k clearance approval.

4- FDA 510k Review- Most FDA 510k application submissions take upwards of 90 days to be reviewed. After the FDA reviews your 510k application, they will either send out a request for more information, testing, and data; or they will approve your FDA 510K petition/application. If your new medical device or product is approved, the FDA will send out your FDA 510k clearance letter with your new FDA 510k device registration number.

5- Final FDA 510k Clearance Approval Process- Once you receive your confirmation of FDA 510k approval, you will have to go to the FDA website and finalize your entire 510k application process. This involves going to the FDA website device registration page to enter your new 510k device number, then you will have to register your business with the FDA as well, A.K.A – Establishment Registration Fee.

All foreign countries have to have you must appoint a US Agent at this time as well. Once forms are submitted online and fees are paid, you are cleared to sell in the USA!

Be advised, after you submit your complete FDA 510k application to the FDA, they have 90 days to review your 510k application and device. While in the review process, the FDA will more than likely request more information from you pertaining to your 510k application and device. If the FDA requests more information then the 90 day review period is put on hold until you send over your responses to the new questions. When your device or product is finally approved by the FDA, you will receive a confirmation of clearance letter that contains your newly approved product or device 510k unique registration number. Immediately after receiving your FDA 510k clearance letter, you must complete the FDA Device Listing and Establishment Registration by going online to the FDA’s website.

FDA 510k Application and 510K Consulting Services

Need Assistance? Let our experienced FDA 510k consultants assist you with getting your new medical device or product FDA approved,