Devices

FDA Takes 1st Steps Regulating 3D Printing

A 5/2016 FDA draft guidance on technical considerations for additive manufactured (AM) devices is the agency’s first attempt to determine its regulation of the burgeoning 3D printing industry. Attorneys Suzan Onel and Jacqueline Chan (K&L Gates) write in an online blog post that FDA’s approach may change as the industry develops.

“Although FDA’s draft guidance provides an initial starting point for AM devices and the regulation of the emerging technology, many unknowns still remain,” they write. “Accordingly, it remains prudent for manufacturers to use FDA’s pre-submission process to obtain more detailed feedback regarding their specific AM device or process.”

The attorneys say that the agency’s Office of Science and Engineering is investigating how the technology may affect medical device manufacturing in the future. Projects include developing and adapting computer-modeling methods to determine the effect of design changes on device safety and performance and studying how different printing techniques and processes affect the strength and durability of the materials used in medical devices, they say. “To the extent that FDA concludes there may be a significant impact on safety or effectiveness,” they add, “FDA may impose more rigorous controls and/or requirements on devices manufactured by AM.”

The extensive and detailed recommendations in the guidance apply to devices that include at least one AM step, Onel and Chan say. The guidance is broadly organized into two main topics — (1) design and manufacturing considerations and (2) device testing considerations. The post outlines some of the major considerations in each section.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome