Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013
http :// www .fda. gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
http :// www .fda. gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
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. As 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.
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.
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