Ask SCB: All About the FDA Standards Recognition Program
In this series, SCB staff answer common questions about standards and the standards development process from the regenerative medicine community.
FDA recently released a draft guidance outlining plans for a Center for Biologics Evaluation and Research (CBER) standards recognition program focused on regenerative medicine therapies. Below, we address some of the key questions we have received about this new program and its impact on the regenerative medicine community.
(Please note that you can register now to join our August 24 workshop to discuss the guidance and collect feedback from the community.)
What does it mean for a standard to be recognized by the CBER program?
FDA has evaluated these standards and determined that they are appropriate for use in the development and manufacture of regenerative medicine products. This means that, while their use is still voluntary, FDA recommends the use of any of these standards that are appropriate for your product.
The program is modeled after the existing Center for Devices and Radiological Health (CDRH) Standards and Conformity Assessment Program for medical devices, which follows a structured process including:
A clear timeline for standard recognition request responses
Inclusion of recognized standards in a searchable database
Publication of supplementary information, including FDA’s rationale for recognition or non-recognition decisions and extent of recognition
Regular updates to the list of recognized standards
How will the new program benefit the regenerative medicine community?
The new program will enhance many of the benefits of standards by increasing confidence that specific standards will be accepted by FDA in regulatory applications. The program:
Provides a mechanism to confirm early in your product’s development whether FDA will recognize a standard before you integrate it into your processes
Allows you to streamline your product development processes upfront using recognized standards, saving time and reducing the chance that the processes will need to be revised later
Reduces guesswork in selecting appropriate standards for use by highlighting standards vetted by FDA, increasing regulatory predictability
Improves efficiency of regulatory review, enabling products to get to market faster
What types of standards will be included in the FDA recognition program?
The recognition program will apply only to Voluntary Consensus Standards (VCS), which the federal government prefers because consensus processes ensure that the recommendations of a standard have broad support from the community. You can learn more about the attributes of consensus-based standards and their development processes in our Standards 101 materials.
Will standards not formally recognized by the program still be accepted by FDA?
Yes, the list is non-exhaustive. Standards not included on the list may still be included in regulatory applications and will be evaluated on a case-by-case basis as part of application review. FDA plans to update the list of recognized standards twice per year to add or remove standards as appropriate.
Where can I find a list of standards recognized under the new program?
Once the program formally launches, FDA will provide a list of recognized standards on its Standards Development for Regenerative Medicine Therapies web page. Additionally, to make it even easier to find FDA-recognized standards, we will highlight them in the SCB Regenerative Medicine Standards Portal.
How can I submit a standard for consideration in the program?
Standards may be submitted to FDA via email at SRP-RMT@fda.hhs.gov once the final guidance is published. The guidance provides a list of relevant details to include in your submission.
When is the program expected to officially begin?
FDA is accepting comments on the draft guidance until September 14, and will then review the comments and finalize the guidance before the program launches. We will provide an update to the community once the program has formally launched.
Join the SCB Webinar to Give Feedback on the Guidance
SCB will be leading a community webinar on August 24 to provide an overview of what the guidance means and how to use it, followed by a group discussion of the guidance to collect feedback. SCB will officially submit consolidated comments from the webinar on behalf of participants, so it’s a great opportunity to contribute.
All input is welcome, including technical or editorial comments, questions or concerns about implementation, and points you would like the guidance to clarify.
Sponsor the Webinar
We are also offering opportunities to sponsor the August 24 webinar. If your organization is interested in sponsorship, please contact our Executive Director Justin Barch directly.