The FDA Office of Counterterrorism and Emerging Threats (OCET) has established a dedicated advanced manufacturing program for innovative, cross-cutting advanced manufacturing technologies to fill unmet regulatory science needs related to rapidly changing and disruptive needs.
Medical products, some food products, and other regulated products are all manufactured by processes that have been developed, tested and refined over time. Industry research and development sometimes identifies new methods for manufacturing that are improvements over previous generations. Every field has a different set of manufacturing techniques that are considered advanced. They often:
- Integrate novel technological approaches
- Use established techniques in a new or innovative way
- Apply production methods in a new domain where there are no defined best practices or experience.
Examples of some advanced manufacturing technologies that can be used across multiple industries and product types (cross-cutting) include but are not limited to continuous manufacturing and 3D printing. Read more: About Advanced Manufacturing for Public Health Emergency Preparedness and Response
To support the development and adoption of advanced manufacturing among regulated industry stakeholders, the OCET Advanced Manufacturing Program helps identify cross-cutting platform technologies and processes. Cross-cutting platforms are typically technologies or processes that can be used in two or more FDA regulated product areas. The program aims to build internal FDA expertise, develop regulatory science tools, and create consistent approaches to regulation, ultimately helping facilitate production of regulated products using these new technologies.
- Enhance collaboration in research, standards, and policy when cross-cutting topics affect many product areas
- Augmenting strong ongoing center research programs with collaborative research opportunities
- Identifying and leveraging shared lessons learned
- Provide resources for intramural and extramural projects specifically focused on supporting advanced manufacturing for public health emergency response and supply chain resilience
- Increasing our understanding of key safety or performance criteria when using these technologies
- Developing benchmarks and validation tools to improve or update evaluation
- Enhance internal training capabilities to build FDA experience with novel technologies
- Providing access to emerging technology demonstrations
- Developing experiential learning and research programs
- Increase internal and external communication and visibility on advanced manufacturing technologies
OCET’s Advanced Manufacturing Program includes:
- HHS and FDA Advanced Manufacturing Innovation Hub
- Smart Design and Manufacturing Pilot
- Various additional advanced manufacturing projects (see: OCET Advanced Manufacturing Research and Projects)
- Advanced manufacturing news & events (including funding opportunities)