Updated Winter 2020 Needed Standards Report Available

In spring 2019, we released a draft version of the Community Perspectives: Needed Standards in Regenerative Medicine report. We also asked for your feedback to ensure the report fully reflects the standards needs that could have the greatest benefit for the regenerative medicine field and improve the safety and quality of regenerative medicine products. The updated, winter 2020 version of the report is now available.

This update incorporates feedback we received from industry, academia, subject matter experts, and standards developing organizations via:

• Direct responses from stakeholders

• Comments on report components collected at recent focused sector workshops

We made some key modifications and improvements in this update, including:

• A new crosscutting standards need area: Transportation Standards for Regenerative Medicine Products

• Updated impact and urgency ratings for three standards need areas

• Revised potential sub-areas that should be standardized to better reflect community perspectives

• Updated related efforts in the regenerative medicine community for each standards need area

• Clarified and refined language throughout the report

We welcome your feedback on this winter 2020 update of the needed standards report. It is a living document that will be periodically updated to ensure it remains a timely and relevant resource for the entire community. If you have suggestions for improving this report, please send your feedback to Sarah Lichtner (slichtner@nexightgroup.com).