Dive Brief:
- The U.S. Food and Drug Administration has released a draft guidance seeking feedback on the agency's initial considerations regarding the use of additive manufacturing (AM), the process that includes 3-D printing, to create medical devices.
- The guidance outlines technical considerations around the process, as well as the FDA's recommendations for the testing and characterization of devices created using least one AM fabrication step.
- The recommendations are based on feedback received from medical device manufacturers, AM companies, and academia during a 2014 FDA workshop, the agency stated.
Dive Insight:
The FDA notes its "leapfrog guidance," which may change as more information becomes available, is not intended to be comprehensive in addressing all considerations and establishing quality systems for 3-D medical device manufacturing.
The presented considerations do include information to provide in premarket notification submissions, premarket approval applications, humanitarian device exemption applications, de novo requests and investigational device exemption applications.
The FDA adds the details and testing necessary for an AM device can depend on numerous factors including whether it is an implant, load-bearing, and whether it is made in standard sizes or patient-matched.
It further notes point-of-care device manufacturing could raise further considerations and the current draft guidance does not encompass the incorporation of biological, cellular, or tissue-based products in AM. The FDA refers any questions regarding AM using biologics, cells or tissues to the Center for Biologics Evaluation and Research (CBER).
The FDA is taking comments on the draft guidance through Aug. 8.