June 2017, Silver Spring.  The FDA issued a notice indicating that it is requiring additional validation data for 40 specific device types for 510(k)s submitted starting in less than two months.  The list of devices ranges from Arthroscopes to Computer Controlled Surgical Systems, and includes almost all ‘scope’ varieties and related accessories: bronchoscopes, endoscopes, laparoscopes, etc.  In the notice, the FDA indicated the new 510(k) requirements address ‘”instructions for use” and “validation data” regarding cleaning, disinfection and sterilization” and that this was a reaction to recent superbug outbreaks such as the one involving reprocessed duodendoscopes in Los Angeles and Seattle, and mandated in the 21st Century Cures Act.  In the notice, FDA also listed twenty design features which 510(k) submissions will need to take into account – most related to areas of the devices where debris could be entrapped and not exposed to the cleaning and disinfection reuse reprocessing.  The specific instructions on how to address these areas will need to be included in the submissions and a validation that such instructions are effective will also be required, and such information should not be ‘new’ to many manufacturers as FDA had issued a guidance for this in 2015.  The notice indicates this additional information will be required starting 7 August 2017, and that this was actually enacted by then President Obama and Congress as part of the 21st Century Cures Act amending section 510 of the FD&C Act to require FDA to issue the notice.  For a complimentary copy of the notice including the list of devices and design features, click here.  If your company is planning to submit a 510(k) for one of the devices on the list and would like to inquire about The CRO Group providing assistance in preparing the documentation, if you recently submitted a 510(k) and have received RFAI (Request For Additional Information) related to instructions for use for reprocessing, or additional related validation data, or if you’re in the Boston area and would like to



Like us to find out how.