A Regulatory Path Checklist

The following is a high-level checklist that outlines the basic parameters of a solid regulatory path. 

FDA Establishment Registration

Have you registered your company as an establishment with the FDA? In the rush to get products to market with the EUA in place many companies bringing devices to market may not be aware you have to register as an establishment with the FDA. Yes…there is a fee.

FDA Submission Budget

There is also a fee to submit a 510(k) or PMA to the FDA. Have you researched and incorporated the submission fees into the budget?

Determine the Intended Use/Indications for Use

What is your device intended to do? Who is it going to help? What claims will your device promote? This is the starting point to plan your regulatory path.

Device Class

Do you know which device class your device will fall under? Do you know the device product code? Is there a device on the market that is similar to your device? Will you need to submit to the FDA or internally document the regulatory path with a Non-Filing Letter? Answering these questions will help determine the device class.

Predicate

While a predicate is a requirement for a 510(k) its prudent to find a predicate for all devices. Unless your device is a radically new technology its always good to see if you can gain insight from similar devices that are already on the market and document the similarities.

Guidance or Special Controls

Once you have determined the device class and predicate find out if there is a guidance document or special controls required for the device. Does your device require biocompatibility testing? FCC testing? Stability or transportation testing etc?

Communicate to the Project Team

As stated above communicate all testing requirements to the project team asap! Have you accounted for FDA submission review time in your project timeline? If you have to submit to the FDA make sure that you communicated to the project team the FDA may have questions or request for additional information that may impact the clearance/approval of the device. Communication is key!!!!!

FDA Device Listing

Its a good habit to list you device right after you completed your regulatory pathway documentation and right before you are ready to launch your device. The FDA requires you update your device listings at least annually but I find its best to do it after the regulatory pathway is finalized (documented your NFL or received clearance or approval). This way you won’t forget it.

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Not clear on each step? Feel free to reach out to discuss your specific regulatory and quality needs. Let O’Connell & Myers help you put these procedures in place and get your product to market.