Nelson Laboratories announces compliance with the FDA Safety and Innovation Act (FDASIA) regarding updated requirements for the registration and listing of medical devices for contract sterilizers of non-exempt devices who do not commercially distribute product.
"Nelson Laboratories is committed to staying up to date on the latest regulations from the FDA," says Sherri L. Robbins, Nelson Laboratories' director of regulatory affairs. "Because we provide ethylene oxide batch release sterilization services for exempt and non-exempt medical devices, and do not commercially distribute product, we now fall under this regulation. Therefore, we have completed our registration with the FDA as a device establishment."
Part of this regulation change requires Nelson Laboratories to list the devices that they perform contract sterilization services on with the FDA. Contract sterilizers such as Nelson Laboratories can only complete a listing after the manufacturer has completed their own listing. To know if you must register devices visit: http://bitly.com/d1zQgB
To continue receiving batch release sterilization services without delay, Nelson Laboratories' non-exempt medical device manufacturers need to register their devices on the FDA webpage that details "How To Register and List."
Before Nelson Laboratories can finish listing a device they will require the device exemption information for exempt devices, or for non-exempt devices, the 510(k), Premarket Approval (PMA) number and the proprietary marketed name of the device. Nelson Laboratories knows the importance of confidentiality and will always choose the "confidential" option when identifying the proprietary name of the device in FDA listing.
Source: Nelson Laboratories