FDA Policy/General

New FDA MOU for Distributed Manufacturing

FDA and the Veterans Health Administration (VHA) are announcing a new memorandum of understanding (MOU) to help increase medical product manufacturing capacity and flexibility, and “improve resilience of domestic supply chains during emergencies, shortages, and pandemics. The MOU is intended to develop requirements for “trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care,” according to a 5/22 agency notice.

The MOU describes distributed manufacturing as a “set of technologies that allows products to be made at or near the point of use. In this case, medical products such as personal protective equipment (PPE), nasal swabs, or even drugs and saline could be made near the point of care to help ameliorate or prevent shortages caused by supply chain disruptions.”

It says a digital stockpile does not store physical goods and products, rather it stores the electronic plans, instructions, and methods to make and test medical products. “While primarily focused on medical devices, novel modalities for pharmaceutical fabrication may make it feasible to digitally stockpile drugs,” the MOU explains. “Using digital stockpiles relies on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines. Ensuring the quality of these products and instilling trust in patients and clinicians is paramount to successful implementation of a digital stockpile.”

The MOU is also intended to outline descriptive and functional frameworks for using digital stockpiles and for creating distributed manufacturing locations. Additionally, FDA and VHA will develop metrics, validation tools, training, and standardized protocols and programs for such operations.

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