 
November 2024
In this Fall edition of the Standards newsletter, learn about the latest resources and opportunities to enhance your use of consensus standards in the design, development, and evaluation of health technologies for medical devices across their lifespans.
Submit comments: Updated draft guidance documents
The FDA has proposed updates to the three Accreditation Scheme for Conformity Assessment (ASCA) guidance documents to reflect lessons learned during the pilot phase of the program. The updates proposed in these draft guidances include, among others:
- Transition from a pilot to a permanent program
- Biocompatibility scope enhancement, adding five new test methods (including ASCA Summary Test Report examples)
- Updates to the Basic Safety and Essential Performance Summary Test Report example
Submit comments by December 23, 2024 to ensure the FDA considers comments on these drafts before it begins work on the final versions of the guidances.
DSCA on the Move: Connecting and Collaborating
Recent Webinar on Standards Use
Terry Woods, director of the FDA’s CDRH Division of Standards and Conformity Assessment (DSCA), participated in a webinar on standards use hosted by the Clinical and Laboratory Standards Institute. More than 600 people attended this event, which featured a robust discussion about how best to use consensus standards on in vitro diagnostic submissions.
FDA-Regulatory Affairs Professionals Society 2024 Roadshow
Many thanks to the Regulatory Affairs Professionals Society (RAPS) for welcoming the FDA’s Gail Rodriguez, PhD, to their San Francisco and Utah chapters in August to talk about all things standards. In addition,the Western Canada RAPS Chapter drew an enthusiastic audience of approximately 100 people for a virtual presentation in September from Jianchao Zeng, PhD., assistant director of DSCA’s Standards Management Program at the FDA.
Need an FDA Standards Speaker?
Would your company or organization like a representative from the FDA to speak about standards and their appropriate use in device submissions? We welcome the opportunity to discuss the ASCA program and how to use consensus standards. Contact us today at CDRHStandardsStaff@FDA.HHS.GOV to learn more!
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Recognition Decisions
Recent Additions to the Recognized Consensus Standards Database
The FDA added the following standards to the Recognized Consensus Standards database:
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ISO 11737-3:2023 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
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ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
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ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
These recognition decisions will appear in the Federal Register, but manufacturers may cite them now. If you would like to recommend a standard for FDA recognition, email CDRHStandardsStaff@fda.hhs.gov.
Consult the Recognition and Withdrawal of Voluntary Consensus Standards guidance for details about the recognition program and what should be included in a recognition request.
Did you know? Tips for FDA device submissions
While using standards in device submissions is voluntary, the FDA strongly recommends that manufacturers cite FDA-recognized consensus standards whenever possible. The use of FDA-recognized consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products, while promoting international harmonization. As stated in the Appropriate Use of Voluntary Consensus Standards (ASCA) guidance and on DSCA’s web page.
- Submitting a declaration of conformity to an FDA-recognized standard generally decreases the amount of supporting documentation needed. For example, when you rely upon a recognized consensus standard, a complete test report may not be necessary to further support the marketing application, reducing the time the FDA needs to assess conformity.
- At a high level, supporting documentation may be necessary to supplement the consensus standard when it does not include sufficient detail to address safety and/or performance aspects of the device. For example, if the consensus standard features a choice of methods, you should indicate in supporting documentation what method was chosen and why it was appropriate for that device. Similarly, if the consensus standard does not include acceptance criteria, you should state the criteria along with a rationale.
Consider participating in the voluntary ASCA program, where standards included in ASCA require only that you submit a declaration of conformity and an ASCA Summary Test Report. Learn more on the ASCA webpage.
Events
Public workshop held: Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
On November 6, 2024, the FDA held a public workshop to discuss the possible expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices. Visit the workshop’s web page for more information.
Save the date: Medical Device Sterilization Town Hall
During the town hall on November 20, 2024, we will discuss new additions to the Recognized Consensus Standards database related to sterilization. Learn more about sterilization for medical devices.
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 web page on FDA.gov to learn more about how you can use consensus standards in your premarket submissions, the standards recognition process, and more.
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