Devices

Multiple Violations at Onkos Surgical

A 2/4-4/4 FDA inspection at Onkos Surgical in Parsippany, NJ, determined that the firm is a specification developer of the ELEOS Limb Salvage System, indicated for use in total knee and hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with select conditions. A 7/21 Warning Letter lists these Quality System Regulation violations:

failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, and to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results;
failure to establish and maintain procedures for implementing corrective and preventive action;
failure to adequately establish and maintain procedures for validating the device design regarding risk analysis; and
failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.

The letter also lists this correction and removal violation: failure to submit a medical device report of correction or removal for an action initiated to reduce a risk to health posed by the device or remedy a violation which may present a health risk.

Onkos was told to promptly correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.

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

Read more

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