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The US Food and Drug Administration (FDA) published its guidance document on the use of additively manufactured medical devices on December 5th, 2017. This is the finalized version of the draft document issued in May of 2016.
The recommendations and considerations outlined in the document are largely the same from the draft document. An interesting comparison of the two documents can be found here. (The draft document is on the left, the finalized document is on the right.)
Major changes/additions include:
- A statement that all the guidelines and recommendations within the document may not be appropriate for all the various additive manufacturing methods. It is the responsibility of the medical device manufacturer to determine and justify which considerations are appropriate for them.
- More information on patient-matched design considerations. This includes considerations when imaging soft tissue to be used in patient-matched designs.
- Addition of “Complex design files” section. This highlights the need to validate any file conversions of the patient data from the patient images to the digital representation used to create patient-matched designs.
- Addition of “Cybersecurity and Personally Identifiable Information” section. The need to protect patient data gathered to create patient-matched devices was highlighted and other guidance documents are referenced.
- Addition of “Validating and Automating Software Process” section. The document points readers to the general FDA guidance on this subject.
- More guidance on validating the quality process for medical device manufacturing and that test coupons may not be necessary if the process is well defined.
Information on non-traditional manufacturing centers (e.g. hospitals) is not addressed in this document. However, the importance of this finalized version is that medical device developers have a much clearer picture of what the FDA expects in an application for a new medical device.