What is Establishment Registration, Device Listing & US Designated Agent?
According to FDA General Control Requirements, establishment registration and device listing are required according to 21 CFR Part 807, prior to marketing and importing a medical device in the U.S.. Foreign establishments must also have a U.S. Designated Agent, thus ensuring that FDA has a reliable contact in the U.S. for regulatory communication and oversight.
How to Register your establishment?
Companies must register their facility with the FDA. Establishment Registration is performed using the FDA Electronic Registration and Device Listing (FURLS) Database. Following initial registration, the registration of the establishment is updated on an annual basis.
The Medical Device User Fee Modernization Act require that any establishment engaged in the manufacture, preparation, propagation, compounding, processing or initial importation of a drug or medical device imported into the United States must register with the FDA and identify:
- The name and address of the establishment; and
- The name of the US Designated Agent for the establishment (relevant for foreign companies only).
How to List your medical devices?
Device listing means submitting to FDA a list of all medical devices that are made, processed, distributed, or imported by a registered establishment for use in the United States. Device Listing is also performed using the FDA Electronic Registration and Device Listing (FURLS) Database. This is typically done at the same time as establishment registration.
How to appoint a US Designated Agent?
According to the regulation set forth in 21 CFR 807.40, foreign companies are required to designate a U.S. Agent as part of the initial registration process and the annual renewal. The responsibilities of the U.S. Agent include the following:
- Assisting the FDA in communications with the foreign establishment;
- Responding to questions concerning the foreign establishment’s products
- that are imported or offered into the United States; and
- Assisting the FDA in scheduling inspections of the foreign establishment.
In addition, if FDA is unable to contact the company directly or expeditiously, FDA may provide information or documents to the U.S. Agent, and such an action is considered to be equivalent to providing the same information or documents to the foreign establishment. The agent has no responsibilities related to the reporting of adverse events involving any of the foreign manufacturer’s medical devices.
How we can help?
- Stein – Regulatory Affairs Consulting Ltd. may perform initial and annual FDA Establishment Registration and Medical Device Listing activities, and, as appropriate, act as the United States-Designated Agent on behalf of a foreign company in accordance with applicable FDA requirements.
