Devices

QS, MDR Violations at Rontis Hellas in Greece

A 7/22-7/25/2024 FDA inspection at Rontis Hellas SA in Larissa, Thessaloniki, Greece, found Quality System and Medical Device Reporting (MDR) regulation issues in the firm’s manufacturing of the Cronus HP PTA OTW balloon catheter. A recently-released 10/28/2024 Warning Letter says the specific violations were:

a process for which results cannot be fully verified by subsequent inspection and test has not been validated with a high degree of assurance and approved according to established procedures; and
failure to adequately develop, maintain, and implement written Medical Device Reporting procedures.

FDA said the company’s response to the first observation could not be evaluated, while the response to the second observation was not adequate. It also said it had determined that Rontis Hellas still does not have an active Electronic Submissions Gateway production account for the electronic submission of MDR reports.

Rontis was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action 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

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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