Devices

QLRAD Marketing Unapproved Medical Device: FDA

FDA says it has learned that QLRAD Netherlands is marketing the RectalPro Endorectal Balloon in the U.S. without marketing clearance or approval. A just-released 7/20 Warning Letter says the agency reviewed the company’s Web site and brochures it distributed at medical conferences in 2015 and 2016 in determining that the device is adulterated because the firm does not have a PMA or IDE in effect for the device as described and marketed. The devices are also misbranded, the letter says, because they were entered into commercial distribution without submitting a premarket notification to FDA.

The letter notes the existence of a 510(k) exemption for manual gastroenterology-urology surgical instruments and accessories, but says the QLRAD device is not exempt because it is intended for a use different from those of legally marketed devices in the generic category. While generic devices of this type are intended to be used for gastroenterological and urological surgical procedures, FDA says, the firm is marketing its device to immobilize the prostate in patients undergoing radiation therapy. “The new intended use raises a series of new safety concerns related to anorectal toxicity, tissue damage, perforation of the rectum, irradiation of healthy tissue, and patient intolerance,” the letter says.

The company was told to stop commercial distribution of the devices for the unapproved uses. FDA also says it is subjecting the devices to detention without physical examination until the violations are corrected.

QLRAD was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, along with documentation of each step and a timetable for completion.

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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