FDA expands 510(k) validation data requirements for reusable devices


emergo-1x1By Stewart Eisenhart, Emergo Group

Medical device market regulators at the Food and Drug Administration have issued a new list of reusable medical devices for which validated Instructions for Use as well as validation data for cleaning and sterilization will be required for 510(k) submissions.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

Want to stay on top of MDO content? Subscribe to our e-newsletter.

Speak Your Mind