Devices

AdvaMed Says 3-D Guidance is ‘Confusing’

The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Technical Considerations for Additive Manufactured (AM or 3-D Printed) Devices” is confusing regarding recommendations on patient-matched devices (patient-specific, personalized or customized). In just-posted comments to the agency, AdvaMed says that to “mitigate this confusion, there is significant benefit to creating a separate, companion guidance for patient-matched devices that addresses not only AM, but also other manufacturing technologies. If patient-matched devices are maintained solely in this guidance, and patient-matched recommendations versus conventional-device considerations are not clearly delineated, then the requirements for patient-matched devices will remain an ongoing source of confusion for both the agency and industry... While we acknowledge that additive manufacturing will drive a surge in patient-matched products, current manufacturing technologies (for example: computer-controlled milling machines) that create affordable, high-quality, patient-matched products are in use today. In this regard, additive manufacturing becomes another technology to manufacture medical devices.”

AdvaMed says that the draft guidance also needs FDA’s current thinking on issues such as data-handling aspects of patient-specific information, privacy, use of patient data for optimization purposes, and informed consent that are not unique to additive manufacturing alone. “Guidance on patient-matched products would certainly qualify as a ‘leap-frog’ guidance, allowing the agency to express current thinking on these critical topics.”

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