- December 7, 2022
- 1:00 PM - 3:00 PM ET
The Food and Drug Administration (FDA) is announcing a public workshop "Appropriate Use of Consensus Standards." The purpose of the workshop is to obtain public input on the appropriate use of voluntary consensus standards in premarket submissions for medical devices. Potential approaches to help facilitate the use of standards in premarket submissions will be discussed.
The Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices guidance provides direction to manufacturers who voluntarily choose to cite consensus standards in their medical device submissions 1. Published in 2018, the guidance describes the appropriate use of consensus standards and explains how to use declarations of conformity and supplemental documentation, if determined to be appropriate. This workshop aims to discuss and obtain feedback with experts across the medical device and conformity assessment communities on the best approaches for using standards most efficiently in premarket submissions.
During the workshop, the FDA Standards and Conformity Assessment Program plans to discuss the following topics:
- Are there existing resources that FDA could improve to better assist medical device submitters with the use of standards in their device submissions (e.g., guidance, websites)? If so, how can they be improved? 2
- How can the FDA further advance the use of declarations of conformity to FDA-recognized standards?
- How can the FDA make it easier for medical device submitters to include the correct supplemental documentation for the standards they cite?
- What tools do medical device submitters need to help facilitate the use of FDA-recognized standards in their medical device submissions?
- What resources do medical device submitters need to encourage the appropriate use of standards in medical device submissions?
This meeting will be held on December 7, 2022, from 1-3 pm ET by webcast only.
The following public workshop agenda is preliminary and subject to change. More information will be made available as presenters and topics are confirmed.
|Time||Subject||Name of Speaker|
|1:00 - 1:15 pm||Introduction||Scott A. Colburn|
|1:15 - 1:30 pm||Background||Terry Woods|
|1:30 - 2:30 pm||
|2:30 - 3:00 pm||Summary and Q&A||Scott A. Colburn|
Online registration is now closed. The link to view the webcast is posted under the Webcast portion of this web announcement.
Please submit your comments regarding the workshop to https://www.regulations.gov/, Docket No. FDA-2022-N-2781 by January 9, 2023.
Please refer to the Instructions for submitting comments (include the hyperlink) to the docket to ensure that your feedback is received.
The resulting discussions from the workshop and comments received in the docket will be taken into consideration.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at https://www.regulations.gov.
For questions regarding workshop content please contact:
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
- 1. Guidance may be downloaded at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
- 2. In this context, "submitter" may refer to the holder of a premarket submission, manufacturer, sponsor, or applicant.