On November 27, 2001, the FDA published in the Federal Register (Volume 66, Number 228) a Final Rule requiring foreign establishments whose products are imported or offered for import into the United States to register with 

FDA and to identify a United States agent.  (See Archives, MediSourceAsia, June, 2002 for agent requirements)

The regulation states; “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or a device that is imported or offered for import into the United States shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment.”    This includes manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, and manufacturers of components or accessories that are sold or leased directly to the end user. So, if you are the owner/operator of such a company, you have to submit what is known as an initial establishment registration.   If you choose, you can use the services of an “official correspondent” in the U.S. to submit your initial registration and keep it current.

The purpose of this requirement is to give the FDA information on where your device is manufactured and who is in charge. The FDA can then schedule inspections more easily and follow-up on any problems with your device.  There is no fee required by the FDA to submit a registration form.  It is very important to understand that submission of this registration form does not mean that the FDA has approved your establishment or your devices.  There are other regulations you have to meet to ensure your facility meets FDA requirements and your medical device can be marketed in the U.S.  We will discuss these requirements in a future newsletter.

To register an establishment, form FDA-2891, "Initial Registration of Medical Device Establishment" must be completed by the owner/operator and submitted to the FDA.  The form can be downloaded from http://www.fda.gov/cdrh/comp/fda2891.html. Instructions for filling out the form can be found at http://www.fda.gov/cdrh/dsma/rlman.html

An owner/operator of an establishment must register themselves and each establishment they own and operate within 30 days after entering into any activity requiring registration.   If a device manufacturer is registering for the first time, the registration form FDA-2891 must mailed to FDA with form FDA-2892 (medical device listing). A contract manufacturer does not have to file form FDA-2892.   (We will discuss medical device listing in the next issue).

Upon registration, the FDA will send an acknowledgement letter with the owner/operator identification (ID) number assigned to the firm.  It takes from 30-90 days for assignment of a registration number. When the registration number is assigned, CDRH will send the official correspondent a validated copy of the FDA-2891 with the registration number.  You can use your owner/operator number as proof that the registration process has been completed until a registration number is assigned.

All registration information must be verified annually and updated if changes have occurred. The FDA sends the annual registration form FDA-2891(a) to all registered firms to be verified, corrected, and returned to FDA. The FDA will mail the FDA-2891(a) form to the owner/operator of registered establishments automatically each year on an alphabetical schedule. The registration year begins January 1st and ends December 31st.

Please note that when changes occur in ownership, establishment name, official correspondent, or addresses, FDA must be notified in writing at the address above within 30 days of such changes. This notification should be a letter that identifies the registered establishment's registration and owner/operator ID numbers with a description of the changes noted above. The letter must be signed by the establishment's official correspondent

Remember, foreign establishments must register, name a United States agent, and list their devices prior to exporting to the U.S.  Also, you should keep a copy of the FDA-2891 form for your records!

Dr. Norman F. Estrin

September 28, 2002