Medical device company Hollywog has received two FDA 510(k) clearances to market its remote controlled devices for back pain.
Becker’s Spine Review
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Simplifying Global Compliance
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Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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The expanded approval covers the Fantom Encore in 3.0 and 3.5 mm diameters.
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The agency wants to hear from stakeholders about “the use of technical specifications guidances and the data standards they contain.”