FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year,” the company says. “The device brings cutting-edge polymer science and evidence-based engineering to bear on a material that has been safely used in other surgical applications for decades.”

FDA has cleared an Iridex 510(k) for the TruFocus LIO Premiere laser accessory, a light combination and reflection viewing system used with the Iridex retina laser systems and is worn on the physician’s head. “The product combines a laser treatment beam from an Iridex laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination lens to enter a patient’s pupil and to view and treat a patient’s retina,” the company says.

DRUGS

FDA has approved Teva’s Cassipa (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence. An agency statement says the approval provides a new 16 mg/4 mg dosage strength of buprenorphine and naloxone sublingual film. The drug was approved through the 505(b)(2) abbreviated approval pathway that relied, in part, on an FDA finding of safety and effectiveness for Suboxone sublingual film to support approval.

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