Devices

No PMA, IDE for Draegar Systems

FDA says an 8/20-9/20/19 inspection at the Draegar Medical Systems operation in Andover, MA, determined that the firm manufactures multi-parameter patient monitoring systems that are adulterated because Draegar does not have an approved PMA or IDE in place and are misbranded because the company did not notify FDA of its intent to introduce the device into commercial distribution. A 1/17 Warning Letter also says the firm’s devices do not meet Quality System Regulation requirements. Specific violations are:

failing to establish and maintain procedures for validating the device design that includes risk analysis, where appropriate;
failing to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements;
failing to establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements; and
failing to establish and maintain procedures for implementing corrective and preventive action.

The letter says the firm’s responses to an FDA-483 were inadequate. It was told to respond with a list of specific steps taken to correct the noted violations and to prevent those or similar violations from recurring, with documentation of each corrective action and a timetable for completion.

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