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FDA

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Guest user Created:   Nov 30, 2020 Last commented:   Nov 30, 2020

FDA

Our company is ISO 13485:2016  certified. We have a new customer who wants us to manufacture and pack hearing aid. As you know FDA doesn't require 510K for Hearing Aid, but the customer wants us to register with FDA. 

Without 510K what will be our company's responsibilities for the product if we decide to register with FDA.
Please advise.

Thank you for your help in advance

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 30, 2020

From your question, I assume that you are outside of the US and that your customer wants to register the product on the US market. FDA registration is the basic requirement for all domestic and foreign establishments that manufacture medical devices in the USA. 

All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement and without US FDA Agent; the registration cannot be completed.

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

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Nov 30, 2020

Nov 30, 2020