What are the Requirements for Medical Device Packaging?
Is a special DMF required for packaging materials used to package medical devices or will a DMF set for packaging materials used for food and drug packaging suffice?
A Drug Master File (DMF) may be established with the Food and Drug Administration (FDA) for materials used to package drugs. Similarly, a Device Master File (MAF) may be established with the Agency for materials used in the packaging of medical devices. For both drugs and medical devices, the safety and the suitability of the packaging are considered during FDA's premarket approval process for the particular drug or device, if premarket approval is required. To protect proprietary information, packaging material suppliers can provide information directly to FDA in a DMF or MAF, and authorize drug and device manufacturers individually to reference the master files in their applications for FDA approval.
The information required to be included in a MAF depends upon the nature of the device being evaluated by FDA; and, in general, it is very similar to that included in a DMF. There are no detailed FDA requirements for the contents of a DMF or MAF. Although, in view of the purpose of the master files, FDA expects some confidential information about the packaging material to be included. Beyond that, and some basic information such as the name and address of the company and a contact person, it is really up to the supplier to determine what information to place in its master file. The decision involves keeping the information as generic as possible to minimize amendments to the file when minor changes occur in the product or the manufacturing process, while avoiding delays in FDA's review of a customer's application when more information must be requested.