510(k) for the Vital Sleep anti-snoring device

The FDA has recently cleared the Vital Sleep anti-snoring device, manufactured by The Snore Reliever Company from Bronx, NY. BesTech wrote and submitted the application. The process took 109 (calendar) days from submission.

Medical errors tending to our young

Sometimes oral medications are administered using parenteral syringes, but these may be accidentally connected to an IV line, even though there are systems to prevent that. The Institute for Safe Medication Practices, in an article  about this subject, again warns against the practice of using parenteral syringes instead of oral syringes.

MDR's must be filed for adverse events overseas!

The FDA called a device "misbranded" in a warning letter to an Italian company because the company failed to file MDR's for adverse events that occurred in Europe. The device is also marketed in the US. The company took the position that non-US adverse events would be exempt from MDR reporting, and the FDA took exception to that, saying "The MDR regulation applies to foreign manufacturers whose devices are in commercial distribution in the US. An adverse event that occurs overseas is reportable under the MDR regulation if the device is one that has been cleared for marketing in the US".
Just so you know!