Master Files for CBER-Regulated Products
What Are Master Files?
For CBER’s purposes, master files (MFs) are voluntary submissions of information to the FDA that may be used to provide confidential, detailed information to the FDA about the facilities, processes, or articles used in the manufacture, processing, packaging, or storing of one or more regulated products. The person holding the MF (MF holder) may authorize one or more sponsors or applicants to reference information contained in the MF to support a submission to FDA without having to disclose that information to the sponsors or applicants. MF holders submit amendments to FDA when changes occur that might affect the product.
FDA ordinarily neither independently reviews nor approves amendments to a MF. Instead, we customarily review the information in a MF only in the context of an application, i.e., when an application or supplement references information contained in that MF.
What Are Master Files for Devices?
Master Files for Devices (MAFs) are MFs that may be used to provide confidential, detailed information [about facilities, manufacturing processes (e.g., sterilization), packaging materials, and contract packaging, as well as nonclinical and clinical study data] associated with Premarket Approval Applications (PMAs), Investigational Device Exemption Applications (IDEs), Premarket Notifications (510(ks)), or other device submissions. As with other MFs, the person holding the MAF (MAF holder) may authorize one or more sponsors or applicants to rely on information contained in the MAF to support a submission to FDA without having to disclose that information to the sponsors or applicants.
Additional information regarding MAFs can be found at https://www.fda.gov/medical-devices/premarket-approval-pma/master-files.
How to Send Master Files to CBER
For CBER-regulated products:
MAFs and amendments to MAFs should be submitted to CBER’s Document Control Center at the mailing address below. FDA recommends submitting these documents per the electronic copy (eCopy) guidance document (eCopy) Program for Medical Device Submissions. An eCopy is an electronic version of a medical device submission stored on a compact disc (CD), digital video disc (DVD), or a flash drive. In lieu of an eCopy, MAFs and amendments to MAFs may also be submitted as paper copies to the mailing address below.
Most other MFs, and amendments to those MFs, that are no larger than 10 GB must be submitted electronically through the Electronic Submissions Gateway (ESG) using the electronic Common Technical Document (eCTD) format. There are some exceptions to this procedure (e.g. submissions of Type III MFs); see the guidance for industry Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Rev.7).
MFs and updates to MFs that are larger than 10 GB, as well as any submission that is not required to be submitted in eCTD format, can be submitted using the ESG or should be mailed on electronic media to the address below.
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002
Guidance for Industry
Drug Master Files – Draft Guidance (October 2019)
Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Rev.7) (February 2020)
Use of a Master File for Shared System REMS Submissions – Guidance for Industry (November 2017)
eCopy Program for Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff (December 2019)
Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (July 2020)
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) included provisions related to the development and manufacture of new medical countermeasures (MCMs) through the use of MCM MFs. Please see the webpage at the following link for information and updates on implementation of FDA-related PAHPAIA provisions, including FDA’s implementation of the MCM MF provisions: MCM-Related Counterterrorism Legislation.
Proposed Rule for the Use of Master Files in Biologics License Applications
On June 28, 2019, FDA issued a proposed rule regarding the use of MFs by BLAs and by INDs for products that would be subject to regulation under the Public Health Service Act. Information regarding the proposed rule can be found at the following link: https://www.federalregister.gov/documents/2019/06/28/2019-13753/biologics-license-applications-and-master-files.