 
July 2024
Welcome to the summer edition of DSCA’s 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 across their lifespans.
New Consensus Standards Recognitions Promote Efficiency and Quality in Regulatory Review
The FDA has updated its Recognized Consensus Standards database. This latest update, known as “List 62,” includes new standards and new versions of recognized standards, as well as a revision to one standard’s extent of recognition. Some highlights:
-
Two new Technical Information Reports (TIRs) related to medical device sterilization:
-
AAMI TIR12:2020 (R2023) – Designing, Testing, And Labeling Medical Devices Intended for Processing By Health Care Facilities: A Guide for Device Manufacturers. This TIR provides direction to manufacturers to develop instructions for processing steps to accompany reusable and single-use medical devices processed by health care facilities prior to clinical use.
-
AAMI TIR28:2016/(R)2020 – Product Adoption and Process Equivalence for Ethylene Oxide. This TIR provides assistance to manufacturers and sterilizers when adding new or modified products to an existing validated ethylene oxide (EO) sterilization process. It also augments the FDA-recognized ANSI/AAMI/ISO 11135 standard.
-
Accreditation Scheme for Conformity Assessment (ASCA)
- An additional standard in the Basic Safety and Essential Performance scope of ASCA: ISO 80601-2-85:2021 (Edition 1.0) Medical electrical equipment: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment.
- New versions for five existing ASCA Basic Safety and Essential Performance standards
-
One standard changed from partial to complete recognition:
- Interoperability Standards for Digital Health:
- Two new standards and six new versions of interoperability standards in the ISO/IEEE and IEEE 11073 series
Visit the Recognized Consensus Standards database for the most up-to-date list of voluntary consensus standards. As outlined in the Appropriate Use of Voluntary Consensus Standards in Medical Devices guidance, declaring conformance and submitting a declaration of conformity to a recognized standard will typically reduce the amount of supporting documentation needed in a device submission. We’ll have more about this least burdensome approach in the fall edition of this newsletter.
Program Updates
How to Cite Standards in eSTAR Submissions
Did you know that citing consensus standards in the electronic Submission Template And Resource (eSTAR) is fast and easy? eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission and is required for all 510(k)s, unless exempted as identified in the eSTAR guidance. eSTAR will even create your declaration of conformity. Visit the eSTAR Program to learn more.
Submit Ideas on ASCA Expansion
Did you attend the April public workshop on approaches to expand the ASCA program? If not, you can listen to the recording and download the workshop slides to learn more. It’s not too late to share your expansion ideas with us by sending an email to ASCA@FDA.HHS.GOV.
Events & Training
Recorded Sessions Available for the May 2024 REdI Conference
This year’s Regulatory Education for Industry (REdI) conference was held on May 29-30, drawing more than 6,500 attendees, many of whom attended in person for the first time in four years. CDRH joined the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to provide industry, educators, and researchers with a foundation in the FDA’s regulatory requirements and to create awareness of current and future activities. Simon Choi, Ph.D., Senior Standards Advisor in DSCA, led a key session on the appropriate use of consensus standards and the ASCA program. If you weren’t able to attend the conference, you can still view the recorded sessions. You can check out Dr. Choi’s presentation as part of the Day 1 recording about medical devices. His introduction begins at 2 hours and 44 minutes into the Day 1 recording.
Engage with Us at an FDA RAPS Roadshow
|
DSCA successfully launched the inaugural “FDA RAPS Roadshow.” Jianchao Zeng, Ph.D., Director of DSCA’s Standards Management Program, highlighted ASCA and the use of standards to over 90 regulatory affairs professionals from the Twin Cities Regulatory Affairs Professional Society (RAPS) chapter and engaged in valuable discussions. There’s more to come — watch for future FDA RAPS Roadshows as we extend our partnership with RAPS to spread the word about the benefit of using standards in premarket submissions.
Book a Standards Expert
Would you like to educate your team or organization about the value and use of consensus standards in medical device premarket submissions and about the ASCA program? We can help! Contact us today at CDRHStandardsStaff@FDA.HHS.GOV to schedule a session or event with our experts.
|
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 Industry or CDRH Science mailing lists. DSCA’s newsletters are also available online.
|
