For many years ISTA test procedures have been referenced in ISO 11607 which serves as the principal guidance document 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, September 21, 2016 ISTA 3A, 3B, and 3E were officially recognized by the FDA as consensus standards and are now present on the FDA’s CDRH Recognized Consensus Standards Database.
FDA Recognizes ISTA Procedures as Consensus Standards
Procedures 3A, 3B and 3E are now present on FDA’s CDRH Recognized Consensus Standards Database.