1st International Course on
Integrated Biomarkers

Biochemical and Bioimaging Endpoints in Cardiocerebrovascular Diagnosis,
Prevention, Therapy and Drug Development


Biomarkers 2005

To facilitate the dialogue among the multidisciplinary scientists, definition of the acronyms and of more specialized terms have been reported. Every amendment is welcome.

Andrea P. Peracino
Stefano Bellosta
Nicola Ferri
Riccardo Roggeri

510(k) Premarket Notification. Medical devices that are substantially similar to products already on the market can usually obtain FDA clearance via the agency's premarket notification process, known as a 510(k).. This review process is required for a few class I devices, most Class II devices and some Class III devices. In a 510(k) filing, the FDA requires that medical device manufacturers provide information and data (which may include clinical data) demonstrating that the new device is substantially equivalent to previously marketed devices and does not raise any new questions with respect to safety or efficacy.
http://www.fda.gov/cder/drugsatfda/glossary.htm '">


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