Category: Regulatory/Compliance
The FDA's Dental Products Panel is scheduled to deliberate on whether the agency should lower blade-form dental implants to a lower risk class.
An FDA advisory panel will consider in July whether to down-classify blade-form endosseous dental implants from the highest risk category to a less stringent class.
The FDA is now proposing to reclassify this pre-amendments class III device into class II because the federal watchdog believes that special controls, together with general controls, can effectively mitigate risks to health posed by these devices, according to the agency's federal register notice.
Symbios Medical Products recalls 2 years' worth of its GoPump systems and GOBlock kits after receiving 5 complaints about the pumps, 2 of which involved serious consequences.
Symbios Medical Products last week recalled all of its GoPump rapid recovery systems and GOBlock kits manufactured with flow control components assembled prior to July 2012, according to the FDA.
These products were found to potentially cause excessively high flow rates, the agency reported. Due to the rapid influx of medication, particularly in patients with low body mass or advanced age, patient toxicity and serious injury including seizure, dysrhythmia and death can result, the FDA noted.
The FDA's Orthopedic & Rehabilitations Devices Panel agrees with the FDA's recommendations that pedicle screw spinal systems be officially down-classified to less-stringent regulatory review.
A panel of experts today recommended that FDA lower the regulatory bar for pedicle screw spinal systems, which are intended to treat degenerative disc disease and a limited type of spondylolisthesis, or shifting of vertebra in response to a vertebral stress fracture.
Stentys launches a clinical trial aimed at backing a pre-market approval application with the FDA for its self-apposing coronary stent.
Stentys SA (EPA:STNT) hoping a new U.S. clinical trial will help it win pre-market approval for a self-apposing coronary stent.
The Princeton, N.J.- and Paris-based medical device company said it enrolled the 1st patient in its Apposition V trial, under an investigational device exemption from the U.S. watchdog agency.
Wound Management Technologies strikes a deal with the IRS to settle payroll tax liabilities and associated charges accumulated between 2004 and 2005.
Wound Management Technologies (OTC:WNDM) struck a deal with the IRS as part of a delinquent tax liability investigation. The company in March ponied up the final $16,000 due under the compromise, according to an SEC filing.
The FDA slaps its highest-risk classification on Abbott Labs' FreeStyle InsuLinx blood glucose meter recall.
The FDA slapped its highest-risk label on Abbott's (NYSE:ABT) blood glucose meter recall, deeming the software glitch potentially deadly for patients.
Abbott last month said that it had already issued a free software update to patch the problem, which may affect as many as 50,000 FreeStyle InsuLinx blood glucose meters on the market.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.
