Regulation of 3D Printing at Health Care Facilities

JAMA Network January 18, 2022
Rita Rubin, MA

Pandemic-related medical device shortages due to supply chain disruption have spurred hospitals, physicians’ offices, and other health care facilities to rely on 3-dimensional (3D) printing to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts from locally available materials.

However, these health care facilities might not be as familiar as traditional manufacturers with how the FDA regulates medical devices, notes the agency, which recently released a discussion paper about 3D printing of medical devices at the point of care.

The 3D printing technology “enables health care professionals to quickly create patient-matched devices and anatomical models for surgical planning, as well as many other uses that can help health care facilities rapidly respond to patient needs,”...

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