Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments on the draft. Read More
What has always been implicit in the FDA’s Quality System Regulation is spelled out in detail in the 2016 version of international standard ISO 13485. Read More
The FDA and the Centers for Medicare & Medicaid Services are transitioning their pilot program for parallel review of medical devices to a permanent program and are asking manufacturers to submit applications. Read More
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