Devices

Implanted Brain-Computer Interface Device Test Guidance

FDA has published a guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation—Non-clinical Testing and Clinical Considerations, with recommendations for Q-submission and IDEs for implanted brain-computer interface (BCI) devices for patients with paralysis or amputation. The document says that because CDRH believes it is important that the agency help stakeholders navigate the regulatory landscape for medical devices, it held an 11/21/14 public workshop to foster an open discussion on the scientific and clinical considerations associated with the development of BCI devices. FDA says it considered the input from the workshop in developing the guidance recommendations.

The guidance provides non-clinical testing and clinical study design recommendations associated with implanted BCI devices, FDA says. Non-clinical device testing can be used to demonstrate that potential risks have been mitigated before initiating a clinical study.

FDA describes the document as a “leapfrog guidance” — a type of guidance that is a mechanism by which the agency can share initial thoughts about emerging technologies that are likely to be of public health importance early in product development. Recommendations may change as more information becomes available, FDA says.

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