Modernization of 510(k) – A major milestone to safer and better healthcare
More than 190,000 distinct medical devices are regulated by the FDA. Data from the years 2017 & 2018 indicates that about 3000, on average, low and moderate-risk medical devices received FDA’s 510(k) clearance. This accounts for 80% of total medical devices approved or cleared. The 510(k) clearance pathway was first framed in the year 1976.…
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