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Marketing its cardiac device — intended to treat chronic angina — for un-cleared uses such as growth of new arteries, reduction of COVID-19 symptoms, regeneration of pancreatic tissue, and hair growth has earned Soulaire, a Santa Monica, Calif., devicemaker, an FDA Warning Letter. Read More
The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have arrived with more questions of their own. Read More
Three plastic syringe makers have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved for sale or distribution in the U.S. Read More
With stern warnings of potential seizure, injunctions and civil money penalties for failure to comply, the FDA’s warning letter to Fresenius Kabi’s spells out multiple areas in need of corrective action in the company’s manufacture of its Ivenix infusion system components. Read More
This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Read More
Lapses in digital security, missed report deadlines, and a complete lack of quality oversight earned manufacturers some notable 483s. And here’s a first: How about getting written up for being too clean? Read More
The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Read More