The FDA's Center for Devices and Radiological Health (CDRH) regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Like devices made using other manufacturing processes, devices made using 3D printing technology are subject to regulatory requirements. Some requirements apply to medical devices before they are marketed (premarket requirements), and others apply to medical devices after they are marketed (postmarket requirements). Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. 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.
In 2016, the FDA issued draft guidance on the Technical Considerations for Additive Manufactured Devices to advise manufacturers who are producing devices through 3D printing techniques. This draft guidance has been published to obtain public feedback and is not final or in effect at this time. The FDA is currently evaluating submissions for new 3D printed medical devices to determine safety and effectiveness. The draft guidance provides manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The type of premarket submission required for a device is still determined by its regulatory classification.
This draft guidance is broadly organized into two topic areas:
- Design and Manufacturing Considerations: This section of the guidance provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable. While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of a device.
- Device Testing Considerations: This section of the guidance describes the type of information that should be provided in premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications for a 3D printed device.
Manufacturers can contact the Division of Industry and Consumer Education (DICE) to answer medical device questions and provide clarification of FDA regulations and policies. They can be contacted via email: DICE@fda.hhs.gov or telephone 1 (800) 638-2041 or (301) 796-7100.