Devices

QS, MDR Violations at Simpro

A 6/17-7/7 FDA inspection at Simpro, Irving, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s importing and distributing of non-invasive blood pressure monitors, fingertip pulse oximeters, and portable fetal Dopplers. An 8/17 Warning Letter from the agency’s Dallas District Office says specific violations included:

failing to establish and maintain procedures for corrective and preventive action;
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
failing to develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses to the inspection observations were inadequate and a follow-up inspection may be required to assure that corrections and/or corrective actions are adequate.

Simpro was told to take prompt action to correct the violations and to reply with the specific steps taken to correct the violations and prevent their recurrence, documentation of each step, and a timetable for completion.

The letter also raises concerns about statements on the company’s Web site that its portable fetal Doppler is “FDA approved” and that its fingertip pulse oximeter is not a medical device. FDA says it recommends that the phrase “FDA approved” be removed from all labeling for the Doppler devices and asks that the company explain why it is saying that its oximeters, which it has listed with FDA as Class 2 medical devices, are marketed as a product that is not considered a medical device.

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