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The total time to get an FDA decision on a 510(k) application submitted through a third-party reviewer improved from 2018 to 2022, the FDA reported, but still missed the agency’s goal of a decision in 108 days. Read More
The FDA issued a Form 483 to RetroFix Screws for inadequate design controls and other deficiencies observed during an inspection of the company’s facility in Salisbury, N.C. Read More
Senior FDA officials at last week’s MedTech Conference in Boston wove the theme of engagement with submitters into a wide array of answers to questions about more rapid development of devices. Read More
In the latest update on the FDA’s Breakthrough Devices program, the agency said that 56 medical devices that received breakthrough designations have gone on to gain marketing authorizations as of Sept. 30. Read More
The COVID-19 pandemic upended the conduct of clinical trials in a number of ways, including the methods used by sites and sponsors for data collection and management. In many cases these changes were a godsend, allowing crucial trials to continue operating while making use of remote monitoring and telehealth technologies that kept face-to-face contact to a minimum. But they also opened the door to a number of data integrity issues. Read More
Indianapolis, Ind.-based medical device cybersecurity company TRIMEDX has partnered with Indiana University (IU) Health to create a cybersecurity lab that will test the security of medical devices as part of the development process. Read More
EndoStim has received the FDA’s Breakthrough Device designation for its EndoStim System for treatment of patients with gastroesophageal reflux disease (GERD) who do not respond to drug therapy. Read More
The FDA’s General and Plastic Surgery Devices Panel met on Wednesday and Thursday to consider the agency’s proposed classifications of seven types of devices, voting in all cases to support its recommendations. Read More