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Choosing the correct pathway for submitting an application to get your product approved by the FDA can be tricky. With multiple different paths available for medical devices, drugs, biologics, and combination products it can easily become overwhelming to try to pick the best path. For medical devices alone the FDA has 5 pathways to market, one of which exempts a manufacturer from the need for a premarket submission[1].

All these different pathways can be confusing and if a product is filed under the wrong pathway the organization submitting will have lost both time and money. Submitting a device under the 510(K) pathway, for example, can cost more the 12 thousand dollars[2]. A product that is inappropriately labeled may even be put on the market without the manufacture realizing that the content of the label makes the product need FDA approval. Understanding the product is key to avoiding this kind of mishap.

Each pathway has a unique set of rules and requirements that allow a product to be submitted under it. Some of the pathways require extensive testing to be done beforehand while others allow a product to be put on the market almost immediately. Some pathways can take years to complete while others take no time at all.

Choosing the correct pathway and filing a submission does not have to be an impossible task. The experts at EMMA International can help choose the correct pathway to get your product on the market and help file the submission. EMMA International can provide assistance during all points of the manufacturing process. For more information on the services available visit www.emmainternational.com. From assisting with regulatory submissions to developing a quality management system, EMMA can help bring your medical product from concept to commercialization. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (February 2018) Step 3: Pathway to Approval, Retrieved 10/21/2021 from https://www.fda.gov/patients/device-development-process/step-3-pathway-approval

[2] FDA (October 2021) Medical Device User Fee Amendments (MDUFA), Retrieved 10/21/2021 from https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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