A device master file (MAF) is a reference source that a person submits to FDA. In
general, it is a file of trade secret or confidential commercial/financial information
submitted by a third party (i.e., someone other than the applicant) for use as a
reference source in support of at least one application. FDA will accept MAFs
from organizations or persons who have not submitted or will not directly submit
the information in a PMA, IDE, 510(k), or other device-related submission to
FDA. MAFs may include information on the following:
• facilities and manufacturing procedures and controls;
• synthesis, formulation, purification and specifications for chemicals,
materials (an alloy, plastic, etc.) or subassemblies for a device;
• packaging materials;
• contract packaging and other manufacturing (such as sterilization);
• nonclinical study data; and
• clinical study data.
We recommend that a MAF include a cover letter, preferably on company
letterhead, signed by a responsible company official that identifies the submission
as a MAF and provides the name of a contact person at the company or a
designated agent.
