New FDA Guidance Released for the Additive Manufacturing (3D Printing) of Medical Devices
May 18, 2018
On December 5th, 2017, the U.S. Food and Drug Administration (FDA) issued Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration staff. The guidance relates to the design and manufacturing considerations for medical devices created with 3D printing, a type of additive manufacturing.

The guidance document provides technical considerations specific to devices using additive manufacturing, which FDA defines as “the broad category of manufacturing encompassing 3-dimensional (3D) printing.” It addresses two topic areas: 1) design and manufacturing considerations that should be addressed as part of fulfilling Quality System (QS) requirements and 2) device testing considerations for premarket notification submissions (510(k)), premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo requests and investigational device exemption (IDE) applications for devices made in whole or in part by additive manufacturing. The guidance notes that it is non-binding and that it “is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing” of additive manufactured devices. Instead, FDA recommends testing and characterization for devices that include at least one additively manufactured component or additively fabricated step.

The type and amount of data to support a substantial equivalence determination or approval will vary and may also depend on other factors such as if the additive manufactured device is an implant, load bearing, and/or is patient-matched. These data include device description, mechanical testing, dimensional measurements, details on material characterization including material chemistry and material physical properties, and biocompatibility. The document further states that the complex geometries of additive manufacturing are expected to increase the difficulty in removing manufacturing material residues (cleaning) and in sterilization due to the likelihood of increased surface area, generation of extensive tortuous pathways, and creation of internal voids with limited or no access. Therefore, FDA states in the guidance that the manufacturer must establish and maintain procedures for the use and removal of such residual manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality.

How Can Exponent Help?

With more than 50 years of experience in solving complex scientific and engineering problems, Exponent is uniquely qualified to assist in the area of medical devices and emerging technologies such as 3D printing.

Exponent is well-versed in current FDA regulations. Additionally, Exponent is actively involved with the additives industry and medical device biocompatibility assessments. The combination of high-level biomedical engineering and materials design analysis, technological expertise, and regulatory experience, along with strong health sciences support, provides a complete team to evaluate diverse issues related to additively manufactured devices. The expertise of our health scientists in exposure and risk assessment, chemical safety, and toxicology allows us to comprehensively examine the potential health consequences of product design, manufacturing and production, and wear.