Devices

QS, MDR Issues at China’s Wickimed

A 9/6-9/14/2021 FDA inspection at Wickimed Medical Equipment Manufacturing Company, HuiZhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of Class 2 sterile single-use disposable electrodes. A just-released 1/7 Warning Letter says specific violations were:

failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to adequately ensure that the results of a process that cannot be fully verified by subsequent inspection and test are validated with a high degree of assurance and approved according to an established procedure;
failing to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
failing to identify by suitable means the acceptance status of a product, to indicate the conformance or nonconformance of product with acceptance criteria;
failing to establish and maintain procedures to control all documents;
failing to maintain device history records; and
failing to develop, maintain, and implement written Medical Device Reporting procedures.

The letter says the agency found the firm’s responses to the inspection observations inadequate but also could not fully evaluate them because they were submitted mostly in a foreign language and without the required complete translation into English.

FDA says it is taking steps to refuse entry of the firm’s devices into the U.S. due to the serious nature of the violations listed. It told Wickimed to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrective actions, and a timetable for completing the work.

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