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# CDRH Seeking Least Info to Declare Standard Conformity
- URL: https://www.fdaweb.com/cdrh-seeking-least-info-to-declare-standard-conformity/
- Published: 2020-10-23T12:00:00.000Z
- Updated: 2026-09-14T16:33:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147942

CDRH officials are looking to identify the least amount of information that device companies need to support a declaration of conformity to a recognized standard. During a 10/15 Web cast ([see transcript](https://www.fda.gov/media/143197/download?ref=fdaweb.com)) on the Center’s recently issued final guidance on *Recognition and Withdrawal of Voluntary Consensus Standards*, CDRH Standards and Conformity Assessment Program director **Scott Colburn** said that this winter the Center is planning additional training for industry on least burdensome approaches for consensus standards use. “We also have the accreditation scheme for conformity assessment pilot platform that’s looking at different approaches too, such as how we can bring that information into a more succinct and focused amount,” he said. “The goal is really trying to make sure that there’s clear communication between how it — a recognized standard — is being utilized or tested to and how that is able to report a regulatory determination in a way that would reduce additional information questions and back and forth because that’s where, you know, any extra effort in developing a declaration loses itself if we're asking questions on that aspect.”

The [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards?ref=fdaweb.com) outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. According to the guidance, FDA:

- Will publish its justification for recognition and non-recognition decisions
- May, when appropriate, determine a transition time for revised standards
- Intends to respond to all recognition requests within 60 days
- Will periodically update the [Recognized Standards Database](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDA5MTQuMjcwNjEyMjEiLCJ1cmwiOiJodHRwczovL3d3dy5hY2Nlc3NkYXRhLmZkYS5nb3Yvc2NyaXB0cy9jZHJoL2NmZG9jcy9jZlN0YW5kYXJkcy9zZWFyY2guY2ZtP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.M9IMgfgb72vyWw9wA8WFWsy0OkPyC5CY7omR8fbFLAo/s/1255931999/br/84846532637-l?ref=fdaweb.com) with pending recognitions.

Consensus standards are big business at the Center, with 17 internal advisory specialty task groups in 23 specific device and scientific areas. “At last count there were about 400 CDRH staff members who participate in around 600 national and international standards committees across 29 standards developing organizations,” CDRH standards advisor **Donna Walsh** said. “There are currently roughly 1,400 recognized standards in our database and more than 90% of those are complete recognitions, meaning that a standard is recognized in its entirety,” she said. “Over the past few years, we’ve typically had a 5% to 10% increase in requests for participation in new standards development activities each year. And based on a past survey that was done there are an average of seven standards cited in each 510(k) submission.”

CDRH standards advisor **Jianchao Zeng** said that those device companies declaring conformance to recognized standards have quicker, streamlined reviews. “So in general the use of recognized standards would be able to help with the reviewers to understand the design and the testing process,” Zeng said. “And then of course yes, if it is a standard that is recognized, both the manufacture and the reviewers understand the test method and the pass/fail criteria.”