Devices

510(k) Pilot for Optical Coherence Tomography Devices

FDA has announced a voluntary Optical Coherence Tomography (OCT) Premarket Notification (510(k)) Pilot Program, which is intended to develop and refine individual premarket testing recommendations for OCT devices through the pre-submission process to yield more consistent premarket submissions and improve review process predictability. “We are planning to achieve these goals through increased interactive engagement with manufacturers of OCT devices, an agency notice says. “FDA intends to use the voluntary OCT 510(k) Pilot Program to assess whether the individual testing recommendations provided through the pre-submission process and increased interactive engagement improve the premarket review process and reduce the overall total time to decision (TTD), a shared FDA-industry commitment goal, in support of the Medical Device User Fee Amendments of 2017.”

OCT devices are used for viewing, imaging, measuring and analyzing ocular structures and may be used to aid in the detection and management of various ocular diseases. Currently, FDA says there are no recognized consensus standards or published guidance documents available that describe performance testing recommendations for OCT devices. “As such, 510(k) submissions, when initially submitted to FDA, often do not include adequate testing to support substantial equivalence,” the agency says. “This is evidenced by consistent requests for additional information (including new data and analyses) across OCT 510(k) submissions, which are unforeseen by manufacturers and may greatly contribute to an increase in TTD for an individual 510(k) submission. Therefore, there is a need for a better understanding of premarket testing expectations for OCT devices and dialog between FDA and OCT manufacturers in order to reduce the need for additional data requests during the 510(k) submission review.”

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