Cross Reference FDA Device Master Files
Afc has submitted Device Master Files (DMF) to the US Food & Drug Administration for
many of our products. Afc is happy to enable investigators, upon written approval of Afc, to cross-reference a DMF in their
own sponsored IND-application.
A Device Master File (DMF) is a submission to
the Food and Drug Administration (FDA) that may be used to provide
confidential, detailed information about facilities, processes or articles
employed in the manufacturing, processing, packaging and storing of one or more
drugs intended for use in humans or animals. The FDA will review information
submitted only upon written request and reference given by the holder of the
DMF. The DMF holder provides the written authorization to the FDA that allows
the review of the Master File to support another regulatory application. The
information contained in a DMF may be used to support an Investigational New
Drug Application (IND), a New Drug Application (NDA), an
Abbreviated New Drug Application (ANDA), another DMF, an Export Application or
amendments to any of these.
DMF Letter of Authorization
As an Afc customer you may request that we
provide reference authorization to our Device Master File(s) in support of a
submission that you have made to the FDA. To initiate the reference
authorization of our DMF, an officer of the company must submit a Request for Authorization
in writing to Afc. The letter must be on company letter head and contain:
Contact name and address
Product(s) cross-reference permission is request for product number
IND number(s) related to the study
The title of the study
Brief description of the study (One or two short paragraphs is all that is needed.)
Once we have your request, we will issue a written Authorization for Cross Reference. Afc is also required to advise the FDA that an Authorization has been issued.
All information contained in a Device Master File is considered confidential to the holder. Neither the FDA nor other outside party may have access to or release the file without the holder's consent.
Afc is also happy to provide information for your submissions to various government agencies.
Questions regarding research, or regulatory information, must be made by an officer of your company in writing to:
Afc/American Fluoroseal Corporation
431-A East Diamond Avenue
Gaithersburg, MD. 20877-5019