All About 3D Printing: An Example of FDA’s Growing Responsibilities

The Alliance’s primary mission involves advocacy for, and education about, FDA. The two cannot be separated. We educate about the Agency’s rapidly growing mission and responsibilities, which is why we are advocates for more resources for the agency (a larger budget, more personnel, and improved technology).

We often talk about why the FDA’s growth is necessary and unavoidable. Our message is:

No federal agency’s mission and responsibilities are more affected by advances in science, technology, innovation, and social trends than the FDA.

New technologies and innovation eventually become part of a medical product or play some role in the food industry.

For this week’s example, I have chosen 3D printer technology. However, I could have just as easily chosen from two other stories this week: FDA Sees Growing Interest, Uptick in IND’s Containing Nanomaterials or An Analysis of the FDA’s List of AI and Machine-Learning Enabled Devices.

Innovative 3D print technology is already widely used. FDA does not regulate 3D printers but does regulate medical products and food created by 3D printing.

Because the technology is mostly behind the scenes, consumers are generally not aware of 3D printing, its broad applicability, and its transformative powers.

However, FDA is certainly aware.

Medical Products. The focus has been largely on medical devices, but at least one drug has been approved because the 3D manufacturing process makes the pill easier to swallow and dissolve.

In December 2021, FDA published a discussion paper, entitled “3D Printing Medical Devices at the Point of Care.” This technology allows customization of medical devices, as well as decentralized manufacturing that can strengthen the medical supply chain. These are both opportunities and challenges.

For those wanting a deeper dive, we suggest two reports from Alliance-member Pew Charitable Trust: What is Medical 3d Printing and How is it Regulated (October 2020) and Printing Can Strengthen America’s Medical Supply Chain (July 2022). Those documents reflect FDA’s challenge with this new technology, as well as chronicle the agency’s progress.

Food Products. Medical products involving 3D printer technology is not the end of the story. This technology is starting to play a role in food supply and food safety.

This week’s, Food Safety News published a thorough and fascinating article, called 3D Food Printers Are Already a Science Fact. Not Far-Fetched Scientific Fiction. The title makes the point, 3D technology has an increasing number of uses in food production, from commercial enterprises to home kitchens.

If you have any doubts that innovative technologies always become FDA challenges, please read the article. For those wondering how food printing is done, we suggest: 3D_food_printing. For those looking for a survey of current products, benefits, and limitations, we suggest: 3D Printed Food: All You Need to Know in 2022.

Use of 3D printing in food is new and faces many challenges including cost and scalability. However, analogies have been made to microwaves in the 1970’s: uses will multiply and unit costs will decrease to the point where they are reasonable investments for restaurants and start appearing in the gourmet kitchens of early adapters.


Editorial Note: This week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.