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Advanced Manufacturing

Innovations in advanced manufacturing support public health emergency preparedness and response. Learn more about FDA's advanced manufacturing activities.

An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)
An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)

On this page: What's new | What is advanced manufacturing? | FDA's role | Science and research | Funding opportunitiesGuidance and information for industry | More information from FDA | Additional resources | Contact FDA

What's new

What is advanced manufacturing?

Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Every field has a different set of production techniques that are considered advanced. They often:

  1. Integrate novel technological approaches
  2. Use established techniques in a new or innovative way, or
  3. Apply production methods in a new domain where there are no defined best practices or experience.

Examples of some cross-cutting advanced manufacturing technologies include continuous manufacturing and 3D printing.

FDA's role

FDA is taking many steps to help realize the potential of advanced manufacturing, including:

  • Issuing guidance on emerging technologies and working with medical product sponsors to clarify regulatory and data requirements necessary to support product applications using advanced manufacturing technologies - Also see Guidance for industry below
  • Reviewing and approving medical products that are made with continuous manufacturing technologies (e.g., New Drug Applications and Biologics License Applications)
  • Advancing regulatory science to proactively address regulatory challenges presented by advanced and continuous manufacturing technologies - Also see Science and research below

3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is spurring innovation in manufacturing. In December 2017, FDA became the first regulator worldwide to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

Also see: The 3Rs of 3D Printing: FDA's Role

Science and research

FDA supports and conducts research to further advanced manufacturing technologies, and the evaluation of products manufactured using these technologies. Ways we do this include:

The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Advanced manufacturing is a priority area, under the focus area “Increasing Choice and Competition Through Innovation.” Please contact FARS@fda.hhs.gov with questions about this initiative.

Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins - FDA/CDER researchers are working to ensure the safety of therapeutic proteins produced by continuous manufacturing (August 2021). 

Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products (October 2021)

The FDA and industry each play a role in ensuring the nation has access to safe and effective medical products even during pandemics and public health emergencies. The COVID-19 pandemic reinforced the need to adopt and accelerate the implementation of ways to increase critical supplies and supply chain resilience. Advanced and smart manufacturing technologies have been identified as potential ways to meet these needs.. 

This FDA-funded study (PDF, 2.2 MB), conducted by MxD and IAAE, aimed to increase the Agency’s understanding of factors that impact a manufacturer’s decision to invest in and adopt digital technologies by identifying both perceived and demonstrated barriers. The project team performed evaluations of nine manufacturers, interviewed representatives, collated the responses, and created a perspective that will allow the Agency to assess areas where it can foster greater manufacturing resilience. Also see: Analysis of the Advantages of and Barriers to Adoption of Smart Manufacturing for Medical Products (infographic) (PDF, 760 KB)

In-house 3D printing facilities

FDA’s Additive Manufacturing of Medical Products (AMMP) core research facility is a multi-center collaboration. It augments Center-specific resources and houses high-end, industry-grade 3D printing equipment, software, and expertise that can be used across the Agency to perform cutting-edge regulatory research with this advanced technology.

The AMMP Lab will establish a scientific foundation to assist the Agency with its assessment of advanced manufacturing, and provide the critical infrastructure FDA will need to meet the regulatory demands of the future. FDA’s in-house 3D printing facilities enable FDA scientists to develop standards and metrics for use of 3D printing for medical products; conduct research to determine how the 3D printing of drugs impacts active and inactive drug components; and identify critical quality processes and controls that affect the safety and performance of drugs and devices.

Academic programs

Many U.S. universities have established advanced manufacturing academic programs. Some of which are funded through FDA grants. For example, in August and September 2018, FDA awarded a total of eight grants, using Cures Act authorities, to institutions of higher education and nonprofit organizations to study and recommend improvements for the continuous manufacturing of drugs and biological products, as well as similar innovative monitoring and control techniques.

Public-private partnerships

To proactively address challenges presented by advanced and continuous manufacturing technologies, FDA representatives actively participate in ongoing public-private partnerships. These partnerships include U.S. government agencies, academia, research institutes, and industry. Examples of these partnerships include federally supported advanced development and manufacturing centers, the Manufacturing USA Institutes, and America Makes. Also see: FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership and 3D Printing in FDA’s Rapid Response to COVID-19

The FDA continues to take creative and flexible approaches to address availability of critical medical products in response to the COVID-19 pandemic. In addition, non-traditional manufacturers and community responders have helped address shortages and gaps in medical supplies during the COVID-19 pandemic, and yielded millions of pieces of equipment and supplies, such as masks, face shields, and other 3D-printed medical devices. In September 2020, the FDA funded a study, conducted by America Makes, to summarize the impact of 3D printing on the overall COVID-19 response. The FDA has now made publicly available this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. The FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies.

America Makes report links (posted July 9, 2021):

Funding opportunities

FDA funding

FDA funds research and development to support regulatory science and innovation under the FDA Broad Agency Announcement (BAA). Advanced manufacturing opportunities may be submitted in areas of interest including:

  • 3.0 Support New Approaches to Improve Product Manufacturing and Quality (examples)
  • 7.0 Facilitate Development and Availability of Medical Countermeasures (MCMs) to Protect Against Threats to U.S. and Global Health Security (examples)

For more detail, and information on funding deadlines for the current fiscal year, see Extramural Research

FDA funding updates

  • October 7, 2021: CDER recently awarded five new extramural research projects totaling over $11 million in advanced pharmaceutical manufacturing areas. The results produced from the extramural research projects are instrumental to the success of CDER initiatives, programs and activities in advanced pharmaceutical manufacturing. These results will be used to evaluate regulatory submissions incorporating advanced pharmaceutical manufacturing (e.g., development of regulatory recommendations for the industry to guide its product and technology development under CDER Emerging Technology Program), provide  knowledge necessary to inform new standards, guidances and policies, develop new tools for more effective surveillance of product quality, and develop materials for training of FDA staff in advanced pharmaceutical manufacturing.

  • October 1, 2021: FDA's Office of Counterterrorism and Emerging Threats (OCET) collaborated with the Center for Devices and Radiological Health (CDRH) to award a contract to Siemens Government Technologies (SGT) to implement advanced industrial software for digital design and an automated manufacturing production demonstration line for regulatory science use in the FDA OCET advanced manufacturing program. The digital showcase will help facilitate evaluation, education, and industry adoption of smart design and manufacturing processes, which can improve performance, speed regulatory review, reduce supply shortages, and increase supply chain resilience in the life sciences industry.

    “The FDA is focused on developing standards, metrics, and data needs for the use of advanced digital design and manufacturing technologies,” said FDA Chief Scientist RADM Denise Hinton. “Furthering the adoption of these new technologies can help increase U.S. manufacturing capacity, increase supply chain resilience, and decrease time to market for medical diagnostics, therapies, and vaccines that are needed for public health emergency response.”

  • September 29, 2021: CBER has funded new FY21 grants to enhance innovations in advanced manufacturing technologies for vaccines against influenza and emerging infectious diseases (four grants), and to support vector manufacturing for diseases affecting very small populations (five grants). 

Other funding

Guidance and information for industry

Recently updated guidance documents specific to advanced manufacturing include:

Search the complete list of FDA guidance


More information from FDA

Emerging Technology Program

FDA established an Emerging Technology Program in 2014 that works collaboratively with companies to support the adoption and use of advanced manufacturing for both new and existing drugs. The team assists companies that want to implement innovative technology, including continuous manufacturing, by helping them to identify and resolve potential scientific and regulatory challenges and providing guidance to their technology development and implementation.


FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing. Video transcript

CBER Advanced Technologies Program

In 2019, the FDA Center for Biologics Evaluation and Research (CBER) established the CBER Advanced Technologies Team (CATT) to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies that are intended to be implemented in CBER-regulated products.

3D printing of medical devices

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for simplicity.

3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

 Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics.

Discussion paper: 3D printing for medical devices at the point of care

On December 10, 2021, FDA posted a discussion paper on 3D Printing Medical Devices at the Point of Care (PoC). The discussion paper provides background information on 3D printing and potential PoC manufacturing scenarios for public comment. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper:

  • Provides relevant background, including terminology, brief overview of the FDA regulation of devices and 3D printing, and how capabilities at a 3D printing facility factor into device safety and effectiveness.
  • Identifies challenges presented by 3D printed medical devices at the PoC and presents a potential approach for regulatory oversight under various scenarios to inform future policy development.
  • Poses questions to facilitate public comment.

FDA is seeking input on each of these topics and on 16 questions posed in the discussion paper. This discussion paper will be open for public comment for 60 days at: https://www.regulations.gov/docket/FDA-2021-N-1272. Also see: FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care

3D printing links


Learn how FDA works with 3D printing for innovative research and regulation.

Other related links

Press, statements, and publications


  • March 16-17, 2022: Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System, 12:00 p.m. - 5:30 p.m. ET both days - FDA is announcing a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. To attend, register by March 14, 2022
  • May 15, 2020: Virtual Town Hall - 3D Printed Swabs, 1:00 - 2:00 p.m. ET - will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency.  This is a collaboration between the FDA, the Department of Veterans Affairs’ (VA) Innovation Ecosystem, and the National Institutes of Health’s (NIH) 3D Print Exchange.
  • March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of advanced manufacturing technologies and methodologies, and discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
  • March 19, 2019: Nondestructive Analytics for Biologics and Continuous Biomanufacturing lecture recording, presented by Bruce Yu, PhD, Professor, Pharmaceutical Sciences and Director, Bio- and Nano-Technology Center, University of Maryland School of Pharmacy - In this CERSI lecture, Dr. Yu provided background on a nondestructive analytical technology, Water proton NMR (wNMR), discussed examples of applying wNMR to inspect FDA-approved biologics (vaccines, vaccine adjuvants, and a therapeutic protein) and a non-biologic complex drug (Ferrlecit), and described how wNMR can be used to improve continuous biomanufacturing.
  • March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology  (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of these advanced manufacturing technologies methodologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
  • October 10, 2018: Manufacturing USA: Securing U.S. Global Leadership in Advanced Manufacturing, hosted by the House and Senate Manufacturing Caucus, and sponsored by American Society for Mechanical Engineers
  • July 30-31, 2018: Continuous Manufacturing for the Modernization of Pharmaceutical Production, co-hosted by FDA and BARDA, with the National Academies of Sciences, Engineering, and Medicine, to discuss the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics (e.g., enzymes, monoclonal antibodies, and vaccines) and discuss specific challenges for process integration across the manufacturing system

Additional resources

Contact FDA

Consumers and general information

Call 1-888-INFO-FDA (1-888-463-6332), or contact the FDA center or office related to your inquiry.


Office of Media Affairs: Email fdaoma@fda.hhs.gov or call 301-796-4540



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