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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
The top clinical areas to receive the breakthrough designation have been cardiovascular, neurology, orthopedic, gastroenterology and urology. 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