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Manufacturers may soon be able to check how their devices are progressing through the 510(k) review process, under an experimental program being developed by the FDA. Read More
The FDA and Centers for Medicare & Medicaid Services have approved the first product ever under the two agencies’ joint pilot program for parallel review – Exact Sciences’ Cologuard, a noninvasive screening test for colorectal cancer. Read More
Makers of low and moderate risk devices can now use the FDA’s de novo pathway to gain approval without first filing for 510(k) clearance – and the FDA wants to encourage more devicemakers to take advantage of the pathway. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, an industry observer says. Read More