> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Draft Guide on Drug Development Tools Qualification
- URL: https://www.fdaweb.com/draft-guide-on-drug-development-tools-qualification/
- Published: 2019-12-13T12:00:00.000Z
- Updated: 2026-09-14T15:56:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145724

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-process-drug-development-tools-guidance-industry-and-fda-staff?utm%5Fcampaign=FDA%20issues%20draft%20guidance%20on%20qualification%20of%20drug%20development%20tools&utm%5Fmedium=email&utm%5Fsource=Eloqua) on “Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.” The document’s development was mandated in the 21st Century Cures Act under section 507, Qualification of Drug Development Tools (DDTs). Once finalized, FDA says the document will represent the agency’s current thinking on taxonomy for biomarkers and other DDTs, and on implementing section 507 with respect to the processes for requestors interested in qualifying DDTs. It does not address evidentiary standards or performance criteria for purposes of DDT qualification, nor does it address qualifying medical device development tools through CDRH.