METADATA
last updated: 2025-12-17 BA
file_name: 2024-04-29_FDA Website - ACLAs Statement on the Final Rule.md
file_date: 2024-04-29
title: FDA Website - ACLAs Statement on the Final Rule
category: regulatory
subcategory: ldts
tags: 
source_file_type: website
xfile_type: NA
gfile_url: NA
xfile_github_download_url: NA
pdf_gdrive_url: NA
pdf_github_url: NA
conversion_input_file_type: docx
conversion: manual cut and paste
license: Public Domain
tokens: 475
words: 308
notes: date converted 2024-06-03
web_url: https://www.acla.com/acla-statement-on-fda-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/
summary_short: ACLA’s Statement on the Final Rule responds to FDA’s April 29, 2024 Final Rule regulating laboratory developed testing services as medical devices and reiterates ACLA’s view that this approach will harm patient access and diagnostic innovation. It argues the rule will increase costs, limit availability of critical tests, and exceed FDA’s statutory authority, emphasizing that clinical labs are already robustly overseen and that any expanded FDA role should come through new legislation.


CONTENT

Washington, D.C. – In response to the U.S. Food & Drug Administration (FDA) releasing its [Final Rule](https://public-inspection.federalregister.gov/2024-08934.pdf) to regulate laboratory developed testing services as medical devices under the Federal Food, Drug, and Cosmetic Act, the following statement can be attributed to [American Clinical Laboratory Association](https://www.acla.com/) (ACLA) President Susan Van Meter:

“The FDA today released a final rule to regulate laboratory developed testing services as medical devices. While ACLA is currently reviewing the rule, our position has been clear and consistent: Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine.

ACLA has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics. The rule also exceeds FDA’s statutory authority, as Congress has never granted the agency authority to regulate laboratory developed testing services offered by laboratory professionals.

We are disappointed that FDA has continued down this path. That is not just ACLA’s view. At a recent [congressional hearing](https://energycommerce.house.gov/events/health-subcommittee-hearing-evaluating-approaches-to-diagnostic-test-regulation-and-the-impact-of-the-fda-s-proposed-rule), it was clear that there is little support for the agency’s approach among members of Congress and key stakeholders. Clinical laboratories are already subject to robust regulation and oversight, and ACLA maintains that new legislation would be required for the FDA to regulate laboratory developed testing services.

ACLA has committed to working with Congress, FDA, and other stakeholders on legislation that would create a regulatory framework tailored to the dynamic nature of laboratory diagnostics. We urge FDA to resume work on legislation rather than unilaterally imposing medical device authorities that Congress never intended for this purpose. The future of patient care depends on it.”

ACLA previously submitted comments addressing the many problems with FDA’s proposal. Learn more [here](https://www.acla.com/fda-proposed-rule-to-regulate-ldts-as-medical-devices-would-slow-development-of-critical-lab-tests-and-should-be-withdrawn-acla-urges/).