Amy K. Dow, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Chicago office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Seeks Comments on Draft 3-D Devices Printing Guidance,” Michael Williamson.
Following is an excerpt:
The draft document outlines the FDA's expectations for addressing the technical differences between additive and traditional manufacturing processes in the design, development and testing of 3-D printed devices, Dow told Bloomberg BNA. In particular, the document is intended to assist manufacturers in applying existing quality regulations to 3-D printed devices and in collecting and submitting the data the agency requires for the clearance or approval of these products, she said.
Manufacturers new to 3-D printing are likely to benefit from the draft guidance, according to Dow. However, she added, it doesn't provide a path forward for manufacturers seeking to use 3-D printing technologies to allow printing of their devices on demand and on-site in health-care facilities where the devices will be used. “The guidance states that point-of-care manufacturing may raise additional technical considerations beyond those addressed in the guidance,” she said.
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