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.
More Articles on the FDA:
FDA Recalls Medtronic Heart Device
New Bill Would Clarify FDA Regulation of Medical Software
FDA Issues Guidance for Medical Apps
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