United States

Legislation

U.S. market (FDA)

The U.S. market accounts for about 46% of the global market for medical devices. It is the main point of reference for companies with a global vision of the market.

The approach to the marketing of medical devices in the United States has generally been tackled by Italian companies entrusting the task of obtaining FDA approval to the first seller or agent with whom they have entered into a commercial agreement.

There are many hidden dangers behind this approach. The main one concerns the ownership of the "FDA approval", which is not the Italian manufacturer but the local dealer. In return the local dealer claims exclusive rights for the whole USA. This means entrusting a vast territory two times the EU to a single representative that is not always the appropriate structure to cover effectively. This problem should not be underestimated, because the termination of the contract of representation, also involves the loss of the FDA approval.

Addressing the U.S. market therefore requires an informed approach and awareness of all aspects of marketing and relations with the authorities (FDA, IRB), as well as the contractual aspects with agents or retailers.

ISEMED has built an effective network with the best US consulting firms to best assist Italian manufacturers in the approach to the U.S. market.

We have designed an integrated programme marketing assistance (see "Marketing support for the U.S.") and FDA approval of the product, leaving the Italian manufacturer with full ownership of the certification. In this way, the manufacturer is able to freely implement their business strategies by managing a strong point of the relationship with local retailers.

ISEMED will be your point of reference for all the services required. There will be interaction with our partners, institutions or companies with reference to each type of service, easing your organization from this problem.The quality of our network has enabled us to achieve the objectives agreed with the client with a success rate of 100%.

Our services include:

• Analysis of Pre-Marketing (see details)

• Pre-Market Notification - 510 (k)

• Pre-Market Approval - PMA

• Investigational Device Exemption - IDE

• Establishment Registration

• Device Listing

• Appointment of Agent for the United States (U.S. Agent)

• Gap Analysis on the quality system

• Implementation of quality system-GMP QSR

• Support for Post-Marketing activities