Even though it is only a requirement for 510(k) products, it is highly recommended to create a Device Master Record (DMR) for each product manufactured. Typically stored in one central location (a binder usually works well for this), it contains all of the pertinent information and background of the product. If a document is not stored in the DMR, there must be a reference to where it can be found.
According to the FDA, “The DMR for each type of device shall include, or refer to the location of, the following information:
- Device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications;
- Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
- Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
- Packaging and labeling specifications, including methods and processes used; and
- Installation, maintenance, and servicing procedures and methods.”
We previously discussed the Design History Files (DHF). While a DHF and DMR might sound similar, they have different inherent requirements. A DHF provides a compilation of records describing the design history of a product in production. The DMR contains the procedures and specifications for a finished product. Another related item is the Device History Record (DHR), which contains the procedures required to manufacture each lot of a device and to prove that it was manufactured in accordance with the DMR (we will discuss the DHR in a future fact-of-the-week). Another way to think of the differences is that a DHF contains all design records from creation to launch (and any changes over time), whereas the DMR is one of the outputs from the DHF containing the specifications which were developed during the design process.