Devices

Q’Apel Selling Unapproved Aspiration System: FDA

A 7/29-8/8/2024 FDA inspection at Q’Apel Medical in Fremont, CA, determined that the firm manufactures the Hippo 072 aspiration system that is adulterated because Q’Apel does not have an approved PMA application or IDE for it. A 2/5 Warning Letter says the system also is misbranded because the company did not notify FDA of its intent to introduce the device into commercial distribution.

The letter says the agency cleared a device that was identified in the firm’s application as the 072 aspiration system, but says that application did not describe the technological characteristics of the device being marketed.

The inspection also found these Quality System Regulation violations:

failure to adequately document design input requirements;
failure to adequately establish and maintain procedures for design verification;
failure to adequately establish and maintain procedures for design change;
failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failure to adequately establish and maintain procedures for document control.

Q’Apel was told to act promptly to address the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing the activities.

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