Devices

QS, Other Violations at Getsch+Hiller Medizintechnik

A 7/18-7/21/22 FDA inspection at Getsch+Hiller Medizintechnik in Nendingen, Germany, found Quality System regulation and other violations in the firm’s manufacturing of monopolar laparoscopic instruments with disposable and reusable instrument tips. A just-released 12/27/22 Warning Letter lists the specific violations as:

failing to establish and maintain a design history file for each of the products the company manufactures; and
failing to establish and maintain procedures for acceptance of incoming product.

FDA says the inspection also determined that the laparoscopic instruments are adulterated because the company does not have an approved PMA or IDE in effect for them. The letter says the instruments received a 510(k) clearance and have been modified to use reusable tip inserts. “Such a change from single-use tips to reusable tips constitutes a change or modification in the device that could significantly affect the safety or effectiveness of the device, for which your firm lacks clearance or approval,” the letter says. It also says the devices are misbranded because the company introduced into interstate commerce a device with significant modifications.

FDA says the firm’s responses to the inspection observations were inadequate.

Getsch+Hiller was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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