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.

DMF Overview

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:

• Institution

• Contact name and address

• Phone number

• Email address

• Product(s) cross-reference permission is request for product number

• Principle investigator

• 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.)

• Request date

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.

Confidentiality

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:

Research Coordinator
Afc/American Fluoroseal Corporation
431-A East Diamond Avenue
Gaithersburg, MD. 20877-5019