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!