Market access USA

Before entering the market, all medical devices should be registered with the FDA. Check how to appoint U.S. Agent.

What institution is responsible for regulating and supervision of medical devices in the United States of America?

The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA).

What is the classification of medical devices in the USA?

The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and Class III. Class I devices are associated with the lowest risk, while Class III devices are associated with the highest risk.

What is the registration process of medical devices in the USA?

Before entering to the US market, all medical devices must be registered with the FDA. Medical devices requires premarket notification. Most class I devices and some class II are exempt from this obligation.

If a device requires the submission of premarket notification, it may not be commercially distributed in the United States until it is authorized by the FDA.

Manufacturers of devices in class III, which present a high risk to the health of patients (and devices that are not substantially equivalent to class I or II) are required to submit an application for approval before placing medical device on the market. The manufacturer cannot initiate any marketing activities prior to obtaining premarket approval (PMA).

Each manufacturer must perform the Device Listing of devices marketed on the U.S. market and comply with the American GMPs.

Who can register a medical device in the USA?

Manufacturers (domestic and foreign) and importers of the medical devices have to register their establishment before introducing their medical devices into the market. All registration information must to be updated annually between October 1st and December 31st of each year. Foreign manufacturers must also designate a U.S. Agent.

What are the responsibilities of the U.S. Agent?

  • assisting FDA in communications with foreign establishment,
  • responding to questions concerning the foreign establishment’s devices that are imported,
  • participation in scheduling inspections of the foreign establishment.