FDA committed to fostering innovation in additive manufacturing.
With the rapid developments in 3D printing or additive manufacturing, ranging from patient specific implants, to instrumentation and external prostheses, the FDA has issued draft guidelines for firms who manufacture, repackage, relabel, or import medical devices in the U.S.
The guidelines were drafted to provide companies with insight into the FDA’s thinking about its technical considerations specific to 3D printing covering two broad topic areas, design and manufacturing, and device testing considerations.
The agency is seeking public feedback and has not finalized any new 3D-specific regulations or submission procedures and requirements at this point. Nevertheless, 3D devices are currently subject to the same regulatory requirements for devices made using traditional processes. These requirements divide medical devices in three classes with increasing regulatory control from Class I to Class III.
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at: Classification of Medical Devices.
The FDA is committed to being involved in all phases of the developments in medical 3D printing. They are conducting research in collaboration with leading universities and industry R&D teams to understand, develop, and foster innovation. They are working with manufacturers and inventors to provide resources for small and large companies allowing access to published developments in medical 3D printing as well as standardization efforts.
The draft guidance provides 3D manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The type of premarket submission required for a device will still be determined by its regulatory classification.
In terms of device design and manufacturing the draft guidelines focus on quality assurance as determined by the device classification. Device testing considerations focus on the type of information that should be included in premarket notification submissions (510k), premarket approval applications, humanitarian device exemption (HDE) applications and investigational device exception (IDE) applications.
The guidelines cover standardized devices as well as patient-matched devices, software workflow, materials control, validation, quality data, testing considerations, measurements, cleaning and sterilization, biocompatibility and labeling considerations.
You can access the draft guidelines at the FDA website. If you are looking for a advisory partner, Kapstone Medical is well versed in regulatory planning, 510(k) submissions, CE Mark and quality systems development.