Draft 2nd Edition FACT Common Standards Available for Public Comment

The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft 2nd edition FACT Common Standards for Cellular Therapies for public comment during a 60-day period. Comments will be accepted from June 1, 2018 through July 31, 2018.

These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.

The final Standards will be published on March 15, 2019 and will become effective on June 13, 2019.

Description and Instructions for FACT Common Standards
Draft 2nd Edition FACT Common Standards

To submit comments regarding the draft 2nd edition FACT Common Standards, follow the steps below. Comments will be accepted through July 31, 2018.

  1. Access the Comment Form at https://www.surveymonkey.com/r/FACTPublicComment. 
  2. Type in your contact information and comments on the form. Fill in all fields to ensure the Standards Committee fully understands your position.
  3. Submit the form when you are finished. Once the form has been submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.

Ongoing Feedback on Current Standards

Comments from the public regarding the current Standards and/or Accreditation Manuals may be submitted at any time. Intermittently, it is necessary update the Standards or Accreditation Manuals based on changes to applicable laws and regulations, field experience, or other reasons. FACT has a process to accommodate needed changes between editions which can be found in the Establishing and Reviewing Standards policy.

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