Those who produce and distribute medical devices intended for use in the U.S. must register annually with the FDA. Most who are required to register with the FDA is also required to list the devices that are made at their facilities and the activities that are performed on those devices. If a device requires PMA or notification before being marketed in the U.S., then the FDA premarket submission number (510(k) and/or, PMA) should also be supplied.
EAS Consulting Group provides US Agent services to international clients in various FDA regulated areas to register the facility or products as needed and acts as a conduit of information between FDA and the foreign firm. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to the U.S. marketplace as quickly as possible.