The U.S. Food and Drug Administration (FDA) has issued recommendations on additive manufacturing processes used in 3D printing for medical applications.
The draft addresses a wide variety of considerations surrounding 3D printing, including manufacturing, printing materials, design path, quality control, pre- and postprinting issues, and file formats. The guidance is nonbinding and follows a meeting between the agency and manufacturers and users of 3D printing devices and materials.
Manufacturers of printing devices and other equipment will be required to maintain separate design and manufacturing controls, just as manufacturers of other medical devices are, the agency said in a May 10 statement. Owing to the great number of manufacturing approaches and combinations of processing steps for 3D printing, each step in the printing process will need to be clearly identified and summarized, the FDA said.
Some of the issues surrounding additive manufacturing include materials chemistry and properties, cleaning and sterilization, biocompatibility, labeling considerations, and patient identifiers.
A PDF of the guidance is available on the FDA's website.
