The Food and Drug Administration has issued a document outlining a voluntary process that can be used to expedite device development and evaluation of medical device development tools in the Center for Devices and Radiological Health.
The proposed process offers a more efficient method of making a qualification assessment on therapeutic and diagnostic devices, specifically biomarker tools, by using more predictable ways to collect information relevant to making the regulatory assessments.
Increased efficiency on regulations can promote innovation, support the manufacture of high-quality products and help effective technologies reach the market quicker, according to the FDA.
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