Owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. There is a fee for annual establishment registration for some establishment types.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Firms like FDARegistration.net are able to quickly and securely process FDA registration submission online for US and non US companies. They offer fast and reliable registration solutions and U.S. agent representation for companies seeking to comply with FDA regulations and FDA standards in order to market their medical device products in the United States. Registering medical device facilities and listing medical device products is the first step in having sucess in the U.S. market.
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