U.S. Food and Drug Administration (FDA)

FDA is U.S. government authority responsible for evaluating, assessing and monitoring food, drugs, medical devices, cosmetics, tobacco products vaccines, blood, biologics, animal and veterinary and Radiation-Emitting products.

Products we service

- Medical devices, include In Vitro Diagnostic Medical Device

- Food

- Cosmetics

How to supply Medical Device in U.S.?

The medical device must register with FDA before place it into the U.S. market.

If this medical device is manufactured in U.S, the manufacturer is responsible to register with FDA.

If this medical device is manufactured overseas, the manufacturer must appoint an U.S. agent before register with FDA.

Responsibilities of a medical device U.S. Agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

- assisting FDA in communications with the foreign establishment,

- responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,

- assisting FDA in scheduling inspections of the foreign establishment and

- if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Kingsmead US can act as your U.S. Agents, please feel free to contact us to find more details.