Inside a medical fiber optics and nanobiophotonics labFLICKR, FDA
With an increasing number of companies seeking to get medical devices on the market and drug makers hoping to formally register an ever-expanding list of biomarkers to more effectively gauge clinical trial outcomes, the US Food and Drug Administration released preliminary rules on its website on Monday (August 15) that will govern both processes.
The guidelines for device makers are extensive and detail the factors the FDA considers when making risk-benefit determinations during the pre-market approval (PMA) process for medical devices. The agency lists several aspects of effectiveness and safety that device makers should consider when testing particular medical devices. The document, which the FDA refers to as a "draft guidance," also provides a handful of hypothetical devices and illustrates how the agency might handle ...
