Devices

FDA Releases Magellan Diagnostics FDA-483

FDA has released the FDA-483 issued after a 5/10-6/29 inspection at Magellan Diagnostics, North Billerica, MA. The company was the subject of a 5/17 agency warning that Magellan Diagnostics LeadCare tests systems performed on blood drawn from a vein may provide inaccurate results.

An agency 7/13 statement (contains link to FDA-483) says the agency takes the inspection observations and risks the tests may have posed to patients very seriously. “We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted,” the statement says.

Inspection observations on the FDA-483 were:

design validation did not ensure that the device conforms to defined user needs and intended uses;
risk analysis is inadequate;
procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established;
procedures for corrective and preventive action have not been adequately established;
a report of the required information about device correction and removal actions was not sent to FDA within 10 days of the correction or removal;
procedures for design changes have not been adequately established;
acceptance criteria were not established before performing validation activities;
a Medical Device Reporting report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
procedures have not been established to control product that does not conform to specified requirements.

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