Important changes to US FDA establishment registration requirements

There are important changes coming soon from the US FDA that may affect your company. These changes concern the US FDA Establishment Registration and Listings and take effect October 1, 2012. Whether you sell finished medical devices or manufacture them for another company, it is important that you be aware of the changes outlined below.

The following changes are part of a final rule which aligns FDA regulations with the mandates of the FDA Safety and Information Act (FDASIA), the Medical Device User Fee and Modernization Act (MDUFMA) and the Medical Device User Fee Amendments of 2012 (MDUFA III). The final rule is published in the US Federal Register, Vol. 77, No. 149, August 2, 2012 and significant changes include the following:

1. ALL finished medical device contract manufacturers and contract sterilizers must register with the FDA (both domestic and foreign entities).

Contract manufacturers and contract sterilizers who did not commercially distribute finished medical devices were previously exempt from the requirement to register. As of October 1, 2012, the final rule eliminates this exemption and applies the registration requirements to these companies as well. The FDA estimates that nearly 750 additional contract manufacturers need to register and list the medical devices that are handled by them.

2. Finished device contract manufacturers and sterilizers now require their own US Agent

If the contract manufacturer or contract sterilizer is not established in the US (no physical address on US soil), the entity will also require a US Agent. We can certainly be engaged as the US Agent for foreign contract manufacturers or foreign contract sterilizers. Please note that this does not apply to component manufacturers that are distributed only to a finished device manufacturer. However, if you are a manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user you must register, list and pay the annual fee. If your finished device is made by a non-US based contract manufacturer, it is very important that you make sure they have appointed a US Agent and registered with the FDA prior to October 1, 2012 to avoid potential supply interruptions.

3. Foreign establishments must identify all US importers (distributors) of their device(s)

Foreign establishments whose devices are imported into the United States must identify all importers known to them. This includes the name of each person who imports (or offers to import) the foreign establishment’s device into the United States.

4. Your 510(k) or PMA number will be required when registering with FDA.

If your device was cleared with a 510(k) submission, or through an approved Humanitarian Device Exemption (HDE) or Pre Market Approval (PMA), this number must be associated with the medical device listing.

This will allow devices to be tracked on the basis of regulatory clearance number(s) which will improve the FDA’s post-market surveillance efforts. However, in Emergo Group’s experience this has always been required in FURLS.

5. Single point of contact and brand names to be required in FURLS.

The FDA collects device registration and listing information using an online system known as FURLS. The final rule requires that each owner or operator identify one contact person within their organization who will be responsible for creating a master account in FURLS for the owner or operator. Moreover, the FDA will require the proprietary and brand names under which each device is marketed to be listed in FURLS.

Read more about the 2013 Requirements for Registration on the FDA web site. Please note that the 2013 fiscal year will commence on October 1, 2012.

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