DryEasy and its parent company are not registered with the FDA. By U.S. law, any bedwetting alarm sold in the U.S. and shipped from a U.S. location, and its related facility, must be registered with the FDA. Any reader who wishes to check whether a bedwetting alarm and/or related facility is registered with the FDA in the U.S. can look at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
and enter the Product Code KPN which is the FDA code for "alarm, conditioned response enuresis" which is a bedwetting alarm. A complete list of all registered parties and items will be shown from the FDA database. DryEasy and its parent company are not registered and listed. Consequently any buyer of the DryEasy buying it from a U.S. shipping source (including Amazon) is aiding and abetting in the violation of U.S. laws until and unless this item is properly registered with the FDA.
We hoped that by pointing out their illegal activity, the owners of DryEasy would register with the FDA as required by U.S. laws and FDA regulations. Unfortunately, as of today, looking at the FDA Establishment Registration & Device listing web-site (see above) we do not find DryEasy to be registered. Apparently DryEasy seems to consider themselves above and beyond the reach of U.S. laws, perhaps because they are based in China. Being very familiar with these issues, there is no doubt that the sale of DryEasy in the United States and being shipped from U.S. locations is a violation of these U.S. laws and regulations. It can result in regulatory fines and other actions against the vendors and shippers of this product in the U.S. No shipper of such unregistered products is exempt from these regulations.
We are informed that the FDA directly, or the FBI (Federal Bureau of Investigation) acting on behalf of the FDA, is looking into taking action against such violators of U.S. law.
This notice is placed on this blog to again warn the owners of DryEasy, as well as sellers and shippers of this product, that they could see actions against them by the FDA and the FBI.
We also repeat that any buyer of the DryEasy buying it from a U.S. shipping source (including Amazon) is aiding and abetting in the violation of U.S. laws until and unless this item is properly registered with the FDA.
No comments:
Post a Comment