FDA Issues New Guidance on 3D Printing of Medical Devices

Jordan Lipp, Esq. | Partner, Davis Graham & Stubbs

Today, the FDA issued new guidance for the industry on 3D printing of medical devices, entitled “Technical Considerations for Additive Manufactured Medical Devices.”  Considering the recent advances in 3D printing technology, especially with anatomically-matched devices that are built for individual patients, FDA guidance on this issue is welcome.  The guidance provides the FDA’s current thinking on the myriad of issues from material controls, process validation, and device testing, to cybersecurity.

This guidance also provides information on labeling considerations involving 3D printed medical devices.  With regards to patient-matched device, the FDA recommends that additional labeling be provided with:

  • patient identifier,
  • use (e.g., left distal femoral surgical guide), and
  • final design iteration or version used to produce the device.

Also, with regards to labeling, the FDA recommends both reviewing whether the expiration date is the same as the typical shelf life for a non-patient-matched device and including a precaution that the patient should be surveyed for potential anatomical changes prior to the procedure.

The newly issued guidance is just a stepping stone.  As the FDA noted in its press release, “our recommendations are likely to evolve as the technology develops in unexpected ways.”  And, of course, as this is a guidance document, so it is nonbinding.

Observations on the Application of Products Liability Law to 3D Printed Technology

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Yesterday I spoke on the products liability implications of 3D printing in the life sciences industry at the Inside 3D Printing Conference in New York, New York. In preparing for my presentation and attending the conference, several fundamental Inside 3D printing.JPGchallenges for products liability law in adapting to this transformative technology became apparent to me, and I provide some of my observations below.

Products liability is an area of tort law that developed in part as a way of incentivizing product manufacturers to ensure the safety of their products by imposing legal liability and financial responsibility on them if their products harm users. In its faltering application to 3D printer “users,” this rationale offers one example of how traditional products liability law doesn’t seem to quite ‘fit’ the new designer-manufacturer-user construction that 3D printing brings about. Continue reading “Observations on the Application of Products Liability Law to 3D Printed Technology”