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The FDA’s Circulatory System Devices Panel will review premarket applications for two investigational renal denervation devices this week, both designed to help control refractory hypertension by ablating some of the sympathetic nerves that wrap around the renal artery. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
The FDA cites inadequate product labeling as the reason for marking Abiomed’s June recall of its Impella RP Flex with Smart Assist system catheter as class I, the most serious type of recall as use of the device may cause injury or death. Read More
Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s). Read More
After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues. Read More
Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal audit to check that regulatory box or if you’re not properly analyzing the data that comes out of those audits, you’re missing a real opportunity, says quality expert says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
Medtronic’s June recall of its Mahurkar Acute Triple Lumen and Mahurkar Acute High Pressure Triple Lumen Catheters, the third recall of the company’s hemodialysis catheters in a year, has been deemed class I by the FDA, because use of the device could cause serious injury or death. Read More
Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. Read More
Make sure to submit electronic or written comments on a guidance by the closing date is the first tip given by CDRH in a list, released Aug. 16, of tips, recommendations and instructions on how to submit comments on a guidance. Read More