Avance Inc
(773) 293-1770
www.avancecounseling.com
4765 North Lincoln Avenue
Suites 203-204
Chicago IL 60625

Rehab Locator

Mix of mental health and substance abuse services
Services Provided: Substance abuse treatment
Type of Care: Outpatient
Special Programs/Groups: Gays and Lesbians, DUI/DWI offenders

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FDA Medical Device Registration

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States must register annually with the FDA, which is a process known as establishment registration. Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee is available at "Who Must Register, List and Pay the Fee." There are no reductions in annual establishment registration fees for small businesses or any other group. Most establishments that are required to register with the FDA are also required to list the devices made there and the functions of those devices. If a device requires pre-market approval or notification before marketed in the U.S., then the owner/operator should also submit the FDA pre-market submission number. The amendments to the Medical Device User Fee Modernization Act require that after September 30, 2007, all businesses submit registration and listing information electronically. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. This information augments the ability of the United States to prepare for and respond to public health emergencies.