Tomorrow, Today! 3D-Printed Medical Devices at the Point of Care

Historically, the manufacture of 3D-printed medical devices at the point of care (PoC) seemed like science-fiction. However, technological advancement, and COVID-19-related developments have forced regulators to grapple with the idea sooner than expected.

On 10 December 2021, the U.S. Food and Drug Administration (FDA) released a discussion paper concerning 3D-Printed Medical Devices at the PoC.

In the paper, the FDA highlight the benefits of 3D-printed medical devices at the PoC, including quick and personalised production. Nevertheless, the FDA also stress the associated risks, and regulatory concerns.

On the risks, the FDA state in their discussion paper:

"In any 3D printing situation, risk is an important consideration, and includes both the risks involved in 3D printing the device…and the risks related to the use of the device." [9]

Specifically, the FDA highlight the following challenges that must be overcome:

1. Assuring 3D-printed devices at PoC are safe and effective,

2. Assuring appropriate quality control of the device at PoC,

3. Clarifying the responsible entity across the product life-cycle, and

4. PoC training.

To combat such risks, and to formulate a regulatory response, the FDA has invited commentary from stakeholders. The FDA advise interested parties should submit their comments by 7 February 2022.

Though these technological advancements provide wondrous opportunities, manufacturers, suppliers, and healthcare providers planning on entering the space must be cautious of incoming compliance and regulatory measures.

Komply can help you navigate current and anticipated compliance and regulatory issues.

Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.

Contact us directly at info@komplyaus.com for more information.