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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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