The very common FDA clearance process for medical devices, called “510(k) notice” after the section of the law, is supposed to be a swift path to market, but it’s not always so.
What’s more, although large swaths of the device industry have been exempted from having to file a 510(k) notice before entering the market, those companies that do have to file 510(k)s will often struggle with knowing exactly what’s expected of them.
