When registering a medical device with the FDA the type of product influences the method of pre-market application that must occur. The pathways available for pre-market application include 510K, De Novo, Premarket approval, and a variety of others. Besides the registration of the device itself, the device must be listed with the FDA by the establishment. When listing the device, the establishment must select what operations they conduct in relation to the device. There are several possible selections for this, depending on the operations listed the establishment may have to fulfill different requirements. Understanding the requirement will help the establishment pass an FDA inspection.
If the establishment lists themselves as the manufacturer, then they are the ones who actually make the device. The manufacturer must follow all parts of the 21 CFR Part 820. They must register, list, and pay any fees related to the device. The devices would be sold in the US and potentially in other countries. This is opposed to another type of establishment called US manufacturer of export only devices. This type of establishment manufacturers the device but does not sell in the US, only in other countries.[1]
If an establishment develops the specifications of the device but does not actually make the device, they are what is known as a Specifications Developer.[1] Despite not actually making the device it is still a requirement for these establishments to follow Part 820. A specification developer would need to work with a contract manufacturer in order to actually have the product made. The contract manufacturer would construct the device according to the specifications provided by the specification developer.1 While the contract manufacturer would also need to follow Part 820, it would be the responsibility of the product owner, most likely the specification developer, to ensure final device quality.
An establishment may do nothing more than package or label the device for final sale. In that regard, the establishment would then be a repackager or re-labeler. Despite merely putting on the final label or doing the final packaging the establishment must still register, list, and pay the fees for the device. The FDA provides information on every kind of establishment both foreign and domestic. EMMA International can help clear up any confusion and submit the proper paperwork for listing. From device development to registering, listing, and getting the device on the market, EMMA International can help with it all. EMMA International provides Full Circle Consulting, 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 (September 2018) Who Must Register, List and Pay the Fee, Retrieved 12/18/2021 from https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

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.

More Resources

Ready to learn more about working with us?

Pin It on Pinterest

Share This