FDA Updates requirements for Medical Device Registration

Created on 28.09.12

The US Food and Drug Administration (FDA) is introducing new requirements and responsibilities for the registration and listing of Medical Devices, effective October 1, 2012. 

The FAQ lists the changes which will occur, and advises how to comply with the new rules. There are sections relevant to manufacturers of combination products, importers of goods and the use of proprietary brand names.

The new regulations result from legislation passed in August 2012, and commence in Fiscal Year 2013, which begins on October 1 2012.

The earlier letter outlining the rules change is also available here




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