Get ready for a slower and more demanding FDA

The FDA has been under fire lately for failures of their oversight processes, and the result is predictable. They're digging in, making the industry pay by demanding more data, more money, and more time. The LA Times has an interesting article about the latest trends.

About OTC (Over The Counter) labeling

An interesting article about OTC labeling argues that shorter labels increase comprehension and reduce resistance to a product. So, if you need to create an OTC label: short is sweet!

Changes to 510(k) process coming

The new CDRH Director, Jeffrey Shuren, has announced major changes to the 510(k) process by the end of the FDA's fiscal year, September 30th. However, he has given no indications of what those changes might be; apparently there will be a public meeting later this month, and the changes are not definite yet. If you are interested in the current 510(k) process, check out the FDA's "simplified" essay and enjoy!

No-Questions-Asked 510(k) OTC-clearance received for Abdominal Toner

One of BesTech's clients, Global Marketing Partners, received OTC-clearance for their abdominal muscle toner. The FDA had no questions or concerns about the 510(k) submission, which reflects very well on the client! They have been very cooperative, made changes to the product at BesTech's request to improve the chance of clearance, and provided all the documentation promptly. Thank you!

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!