 
April 2024
Welcome to the inaugural edition of the Standards Newsletter from the Division of Standards and Conformity Assessment (DSCA) at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Learn about the latest resources and opportunities to enhance your use of consensus standards in the design, development, and evaluation of health technologies across their lifespan.
Quality Management System Regulation Final Rule Promotes Regulation Consistency
Our big news so far this year is the publication of the FDA’s final rule ‘incorporating by reference’ the medical device quality standard ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes into FDA regulations. This rule will have a profound effect worldwide by harmonizing the widely relied-upon ISO standard with FDA requirements. This rule becomes effective on February 2, 2026. Learn more about the Quality Management System Regulation (QMSR) Final Rule and how it promotes consistency in the regulation of devices.
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New Consensus Standards Recognitions Promote Efficiency and Quality in Regulatory Review
The FDA recognized the following sterilization standards and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes:
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ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
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AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources.
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AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization.
These recognitions were key in the FDA’s update to the final guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. Visit Sterilization for Medical Devices to learn more.
We also recently recognized:
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ISO 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
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ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
Visit the Recognized Consensus Standards database for the most up-to-date list of voluntary consensus standards to which the FDA will accept a Declaration of Conformity for medical devices. The database is searchable by several criteria. If you click on “search” without specifying any criteria, all recognized standards will appear, with the latest decisions listed first.
Program Updates
The Accreditation Scheme for Conformity Assessment Becomes a Permanent Program
In September 2023, the Accreditation Scheme for Conformity Assessment (ASCA) transitioned from a pilot into a permanent program.
We encourage medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality. The voluntary ASCA Program is an accreditation scheme that capitalizes upon the increasingly prominent role that consensus standards play in regulatory science and practice.
Device sponsors and FDA review staff are providing positive feedback about the efficiencies associated with the ASCA program. We encourage you to consider using ASCA-accredited labs for your testing needs. They have demonstrated their competence and they have our confidence.
Check out the benefits of the ASCA program and learn more by reading the ASCA Consolidated Pilot Final Report and 2023 Annual Report. Email ASCA@fda.hhs.gov if you would like to receive notifications about ASCA.
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Events & Training
April 17: Virtual Workshop on ASCA Expansion
Are you interested in learning more about the ASCA program and sharing your perspectives about potential expansion of the program? Please register and join us for a virtual public workshop on April 17, from 11:00 a.m. to 1:00 p.m. EDT. Register by April 16 at 4:00 p.m.
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Organizational News
Standards Program Elevated to the Division of Standards and Conformity Assessment
In the recent reorganization of the Office of Strategic Partnerships and Technology Innovation (OST), the newly established Office of Readiness and Response includes the Division of Standards and Conformity Assessment, or DSCA, which was formerly the Standards and Conformity Assessment Program (S-CAP). This elevation of our program to a division recognizes the increasingly prominent role consensus standards play in regulatory science and practice, and better prepares us to advance CDRH’s important standards work.
Meet DSCA’s new leadership team (pictured from left to right):
- Terry Woods, Ph.D., Director
- Eric Franca, Ph.D., Assistant Director, Conformity Assessment Program
- Jianchao Zeng, Ph.D., Assistant Director, Standards Management Program
Scott Colburn, former Director of S-CAP, is now the Director of the Office of Readiness and Response and will continue to support standards and DSCA in his new leadership role.
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Contact Us
The Division of Standards and Conformity Assessment (DSCA) seeks to promote patient safety, advance regulatory science, and support a least burdensome regulatory framework. We value your feedback. Please send us your comments, questions, and ideas for future editions of the Standards Newsletter by e-mailing DSCA at CDRHStandardsStaff@FDA.HHS.GOV.
Visit our pages on FDA.gov to learn more about how you can use consensus standards in your premarket submissions, the standards recognition process, and more.
Subscribe to Our Standards Newsletter
If you received this Standards Newsletter from someone else or you want to make sure you receive future editions, please subscribe to CDRH Science. DSCA’s newsletters are also available online.
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