MEDICAL DEVICE/IVD FDA ESTABLISHMENT REGISTRATION & LISTING

by Arianna Lane marketing head

Any establishment concerned with manufacture and distribution or reprocessing/relabelling of a medical device/IVD should register annually with the US FDA. This is often known as “Establishment Registration” and it is a separate method from getting 510(k) clearance or Pre-Market Approval. Most establishments that are needed to register are also required to list the medical devices/IVDs and the activities that are performed on the medical devices/IVDs at the establishment.

Annual Establishment Registration information should be submitted each year between October 1 and December 31, even if no changes have occurred. Listing information should be reviewed each year between October 1 and December 31, at the same time you can review your registration information. Any updates are to be submitted at the same time.

Initial FDA establishment registration and /or listing information is to be submitted within 30 days of an establishment beginning an activity or putting a medical device into/IVD into commercial distribution. Foreign establishments should register before exporting their products to the United States and domestic importers must register before importing their products. It should be noted that if your medical device/IVD requires premarket notification clearance or approval, you are required to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the medical device/IVD.

The medical device/IVD establishment registration is a two-step method. Initially, you must pay the annual registration user fee and once you have paid the fee you can complete the registration process. The registration is not complete unless you have:

· paid your annual registration user fee

· submitted your registration and listing data electronically, and

· received an e-mail notification from FDA that every requirement is met

Kindly go through and let me know if it requires any change.