This is pretty much a no brainer in concept as many of the new devices and what is being approved revolves around software, thus they might think about understanding the basic concepts of what software (algorithms) does. Actually this could be a good move as more would perhaps jump into the consumer digital awareness arena. <Algo Man = Algorithms>
The FDA can be very transparent, but will they understand what is going on is the big question. Software unfortunately is not perfect and we have more devices that report and record data today and depend on it, so a general summary for transparency that they want won’t cut it. BD
A bipartisan group of U.S. House representatives send a letter to the Food & Drug Administration asking for more transparency and greater detail from the watchdog agency as it implements changes to the 510(k) medical device clearance process.
Six Democrats and six Republicans from the U.S. House Energy and Commerce and Health, Education, Labor and Pensions committees signed the letter, writing that at least five of the FDA's proposed changes are "controversial."