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FDA Draft Guidance on Medical Devices

The FDA has issued a new draft guidance on additive manufacturing (AM) for medical devices. The guidance lays out a clear framework for manufacturers to accelerate innovation and reviews many of the technical issues, Quality System requirements, and testing considerations that should be addressed in an AM programme.

Background on Additive Manufacturing

AM is a fast-growing manufacturing technique inclusive of three-dimensional (3D) printing technology. Device manufacturers can rapidly prototype and create custom, complex devices as a single piece through AM, which builds objects by iteratively stacking two-dimensional layers of material. Many believe that, in the future, AM will become progressively more integral to the manufacturing of medical devices and implants.

AM technology has many healthcare applications. For instance, AM technology can help surgeons prepare for and perform surgeries. With little training, a surgeon can use an individual patient’s data from 3D imaging sources, such as computed tomography scans or magnetic resonance imaging, to construct anatomically-matched devices, prosthetics, and surgical guides. These products can make surgery quicker, safer, and custom to a patient’s unique characteristics.

AM technology can also be used to synthesise pharmaceuticals. In fact, on March 22, 2016, the FDA approved the first 3D printed drug: Aprecia's epilepsy drug SPRITAM. SPRITAM is easier for patients to swallow because the pill rapidly disintegrates in a patient’s mouth. This feature is the result of employing a 3D printing technique that creates tablets without using compression. This technique can potentially help physicians medicate the 40 to 50 per cent of adults in the US who report difficulty swallowing pills.

The FDA has cleared more than 85 applications for 3D printed medical devices, including printed cells, organs, tissues, and skin; implants for the knee, hip, acetabulum, and spine; cutting guides for ear cartilage, mandibular space maintainers, dental mesh, cranial plates; and plates for tumour cases. However, the FDA has yet to approve a high-risk device that requires premarket approval. 

To better understand the AM challenges in the medical device space, the FDA held a public workshop in October 2014 entitled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Based on the feedback they received, the FDA developed a new draft guidance for medical device manufacturers entitled “Technical Considerations for Additive Manufactured Devices.”

About the Guidance

The FDA issued a new draft guidance document on May 10, 2016 for public comment. It outlines the overall AM process, which consists of the following steps: (1) design, (2) software workflow, (3) creation of a build file while concurrently establishing material controls, (4) post-processing, and (5) final finished device testing and characterisation.

The draft guidance includes associated technical considerations and recommendations that manufacturers should consider throughout this whole process, including the development, production, process validation, and final finished testing phases of devices.

There are many variables that affect how the AM process is conducted, such as whether or not the device in question is an implant or is load bearing, and whether it is available in standard sizes or is custom-fitted to the patient. Generally, the FDA will subject AM devices to the same classification and regulatory requirements to which they currently subject non-AM devices of the same type.

The draft guidance follows the overall AM process and is organised into two topic areas: (1) Design and Manufacturing Considerations (Section V) and (2) Device Testing Considerations (Section VI).

The Design and Manufacturing Considerations (Section V) addresses fulfilment of Quality System requirements for AM and includes the following:

  • Device Design
  • Software Workflow
  • Materials Control
  • Post-Processing
  • Process Validation and Acceptance Activities
  • Quality Data

The Device Testing Considerations (Section VI) addresses pre-market notification submissions information and includes the following:

  • Device Description
  • Mechanical Testing
  • Dimensional Measurements
  • Material Characterisation
  • Cleaning and Sterilisation
  • Biocompatibility
  • Additional Labelling Considerations

If you need any assistance with implementing this new guidance from the FDA once it has been accepted, please contact ICON.

Melvin G. Fletcher III 
ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor
ICON Regulatory Services

JoAnne Bronikowski, BS, RAC
Sr. Manager, Regulatory Affairs
ICON Medical Device Regulatory Services

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