> ## 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.

# FDA ‘Discussion Paper’ on Laboratory Developed Tests
- URL: https://www.fdaweb.com/fda-discussion-paper-on-laboratory-developed-tests/
- Published: 2017-01-24T12:00:00.000Z
- Updated: 2026-09-14T22:02:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137814

Three Sidley Austin attorneys say that FDA took the unusual but not unprecedented step of issuing 1/13 a paper, “Discussion Paper on Laboratory Developed Tests (LDTs)” that proposes a new regulatory framework for such tests. Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=26cba8a4-7593-4f1a-8bf7-6ec2f1fb5fa1&ref=fdaweb.com), the attorneys say the paper describes a risk-based approach that differs significantly from the agency’s initial 2014 draft guidance and reflects what they call a “lighter touch” for most LDTs.

The discussion paper is not enforceable, they note, does not represent the agency’s formal position, and is not a final version of the draft guidance. “Rather,” the post says, “issuing the paper allows FDA to publicize, gauge, and build support for its proposals on a controversial topic, while avoiding the requirement that it provide notice to Congress 60 days before issuing any final or draft guidance on LDTs.”

The attorneys cover key provisions in the discussion paper on prospective oversight; grandfathered products; traditional, low-risk, and other LDTs; premarket evidence; LDT modifications; quality system requirements; and conventional IVD kits.

It also discusses notable differences from the 2014 draft guidance.

“If history serves as a guide,” the attorneys write, “FDA likely will solicit further stakeholder participation regarding the new proposals outlined in the discussion paper, possibly by holding a public workshop. Industry should carefully consider the proposals made in the discussion paper and be prepared to provide meaningful input.”