Devices

Multiple Violations in ReNovo Inspection

A 5/15-5/18/2023 FDA inspection at ReNovo, doing business as Provision Device Reprocessing Solutions in Bend, OR, found Quality System Regulation and other violations in the firm’s reprocessing and distribution of several single-use medical devices. A just-released 10/13/2023 Warning Letter says the firm’s devices were adulterated because ReNovo does not have an approved PMA for them. The devices also were misbranded, it says, because the firm did not notify the agency of its intent to introduce the devices into commercial distribution.

The letter describes the multiple misbranding violations for the devices and lists these Quality System violations:

failing to adequately establish procedures to control product that does not conform to specified requirements; and
failing to adequately establish procedures to control environmental conditions.

FDA says the firm’s responses to the Quality System observations appear to be adequate. The letter tells ReNovo to take prompt action to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step 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