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# Changes in Special 510(k) Guidance
- URL: https://www.fdaweb.com/changes-in-special-510-k-guidance/
- Published: 2019-11-08T12:00:00.000Z
- Updated: 2026-09-14T15:52:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145462

CDRH Office of Product Evaluation and Quality regulatory advisor **Joshua Silverstein** says FDA revised a 9/28/18 draft guidance on a proposed new Special 510(k) policy in response to comments received on it. Speaking during a CDRH [Webinar](https://www.fda.gov/media/132460/download?ref=fdaweb.com) on the finalized guidance that was issued 9/13, Silverstein said some 130 comments were received from 13 groups or individuals including medical device manufacturers, trade associations, patient advocacy groups, and consulting firms. Minor changes were made to the final guidance, he said.

The three areas that received the most comments were eligibility factors, examples included in the draft, and requests for clarification to the overall policy.

For the eligibility factors, FDA updated well-established methods to include those that are found in final FDA guidance documents and qualified medical device development tools, Silverstein said. The list in the final guidance is not all-inclusive and Silverstein said that those who believe that they have a method that is well-established should submit a pre-submission request to discuss the proposed method with the review team before submitting a 510(k).

Many comments asked for more in-vitro diagnostic device examples, and Silverstein said the final document includes several new examples. It also has general policy updates, including a clarification that the final Special 510(k) guidance does not supersede recommendations in other guidance documents.