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!

How dense can one get?

The FDA is warning that scammers impersonate FDA "special agents", see their web entry. Apparently people who have bought drugs over the Internet are threatened and told to wire a "fine" to some offshore bank account. I hope none of my blog readers fall for that! Remember, no matter what, only an US Judge can impose fines, payable to the US Treasury!

FDA opens office in Mexico City

The FDA has opened an office in Mexico City to help enforce its regulations for food- and medical device safety. "FDA experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations", said Murray M. Lumpkin, M.D., U.S. FDA Deputy Commissioner for International Programs. See the Press Release.

Changes to the 510(k) process

In light of recent developments, such as allegations of improper 510(k) clearances instigated by FDA officials, and the removal of Dr. Schultz as head of CDRH, many people expected the FDA to change the 510(k) process drastically. But this may be further off than you think, according to Dr. Jeffrey Shuren acting CDRH director, in an article in the Startribune.

FDA watches your website!

Recent warning letters declared products "adulterated" (that's not good!) because of unauthorized claims on the manufacturer's website. In particular, you are not allowed to advertise your product for uses that are not covered by the 510(k) clearance or the PMA. For instance, an powered muscle stimulator that was cleared for pain management and massaging may not be advertised for muscle toning or something similar, even though you could possibly get 510(k) clearance for that intended use also. Forewarned is forearmed: be very careful not to go overboard with your website claims because the FDA is watching!