Changes in Final Additive Manufactured Device Guidance

A 1/10 CDRH Webinar reviewed three changes that were made between a draft and final guidance on technical considerations for additive manufactured medical devices (3D printing). CDRH Additive Manufacturing Working Group member Matthew Di Prima said the changes were made in response to 294 comments from 29 commenters on the 5/2016 draft guidance.

The first change added a section on cyber security and personally identifiable information. Di Prima said that new section solely points to existing guidance and does not represent any new guidance or policy.

The labeling section was updated, he said, to make it consistent with other guidance documents and to clarify that labeling concerns only apply to patient matched devices.

For the third change, most instances of the word “cleaning” were replaced with the phrase “removing manufacturing material residue” in what became known as the Cleaning and Sterilization section.