Devices

QS Violations in Unapproved Spectrum Devices

A 4/14-4/27/2023 FDA inspection at Spectrum Medical in Gloucestershire, UK, found Quality System Regulation violations in the firm’s manufacturing of unapproved Quantum Perfusion Systems medical devices. A just-released 9/29/2023 Warning Letter says the firm markets several devices with indications beyond what the agency cleared in its 510(k) for the devices. The letter says changes to the device’s scope of indications required the submission of a new 510(k).

The letter also lists these Quality System violations:

failure to adequately establish and maintain procedures that include requirements for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; and
failure to adequately establish and maintain procedures that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.

The firm’s responses to the inspection observations were not adequate, FDA says.

Spectrum was told to take prompt action to address 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 each step 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