• Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance

Podcast on Standards & FDA’s Release of these Guidance Documents

FDA’s Captain Scott Colburn and Leo Eisner of Eisner Safety Consultants did a podcast with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation…

Some of items of note with the Final FDA Guidance include:

• FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates
• Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)
• DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 – Supplier’s DOC – Supporting Documentation per section IV. A. (2) of the Final Guidance

IEC 60601-1, edition 3.2 (draft) and it’s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this podcast.

FDA Guidance Documents – Additional Information

The draft guidance will be open for public comments and suggestions for 60 days at https://www.regulations.gov under Docket Number: FDA-2018-D-2936.

The Appropriate Use of Voluntary Consensus Standards final guidance describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.  This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:”

Webinar about the Appropriate Use Final Guidance:

FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers & others interested in learning more about the Appropriate Use final guidance. No registration is required.

• Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)
• To hear the presentation and ask questions:
  Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8090070&p=2387655&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo “the IEC 60601 Guy” Eisner to help you thru this process at Leo at EisnerSafety dot com or schedule a call with Leo.