AOPA Submits Comments to the FDA on 3D Printing


AOPA has submitted comments on the publication entitled Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff which was published in the Federal Register on May 10, 2016.

AOPA submitted comments pertaining to additive manufacturing in the design and fabrication of external prosthetic components and orthotic devices, specifically through the use of 3-D printing. The comments submitted reflect that AOPA does not believe that either additional or lesser regulatory burdens should be placed on manufacturers of prosthetic components and orthotic devices solely based on the decision to utilize an additive manufacturing process into their fabrication protocols.

An excerpt of the comments:

“AOPA firmly believes that the manufacture of a prosthetic component or orthotic device is only a small part of the creation of an artificial limb or orthoses that meets the individual needs of a particular patient. The components that are included in the completed prosthesis or orthosis must be adjusted, and aligned by a properly educated, trained, and certified or licensed healthcare professional such as an orthotist or prosthetist. 

AOPA fully supports the role of the FDA in ensuring that medical devices, including prosthetic and orthotic devices remain safe and effective, but believes the current direction of the FDA, as outlined in the draft guidance document, to not alter regulatory requirements solely as a result of the use of additive manufacturing is appropriate…. (FDA’s stated position) will encourage the development of technology while assuring that devices created through additive manufacturing remain safe and effective for use by the general public, and maintaining consistency and a level regulatory playing field for the devices without regard to the specific method of fabrication employed by the manufacturer.”

Read the comments submitted.