FDA recognizes ISTA procedures as consensus standards

27 January 2017

For many years ISTA test procedures have been referenced in ISO 11607 for validating terminally sterilized medical device packaging systems. Recently ISTA took the steps required to also have ISTA 3A, 3B, and 3E directly recognized by the FDA. With the FDA’s announcement in Vol. 81, No. 183 of the Federal Register on Wednesday, 21 September 2016 ISTA 3A, 3B, and 3E were officially recognized by the FDA as consensus standards (Logistics Life Sciences, 6 December 2016). On 23 December 2016 the newest version of ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems was also mentioned in the Federal Register of the United States Government.
Click here for the news article in Logistics Life Sciences.
Click here for the FDA’s announcement the Federal Register on 21 September 2016.
Click here for the FDA’s announcement the Federal Register on 23 December 2016.
Click here for more information about the online NVC E-course Packaging for E-commerce.
Click here for more information about the NVC innovation project Web Retail Packaging.

If you have any questions about this subject, please contact us: info@nvc.nl, +31-(0)182-512411. This item is also included in our monthly overview, the NVC Members-only Update.