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The FDA issued draft guidance on the 510(k) Third-Party Review Program Friday, focusing on accreditation of reviewers and providing a far greater level of detail, at 34 pages, than the eight-page version issued in 2013. Read More
One of the most important considerations device manufacturers will make before entering China is whether the device will be manufactured locally or not. Read More
The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
The FDA is attempting to harmonize performance standards with International Electrotechnical Commission standards for certain X-ray imaging devices. Read More
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More