The CAP promotes a favorable, effective regulatory environment through its engagement with the Congress, Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and other industry groups regarding the oversight of laboratory-developed tests (LDTs).
When engaging with Congress and federal agencies on LDT oversight, the CAP advocates to protect patients and to provide access to safe diagnostic tests with a framework that is the least burdensome for laboratories. Any extraneous provisions included in legislation or regulation interfere with the goals of ensuring access and quality tests for patients. Oversight of tests also should be based on risk to the patients we serve and not necessarily the setting where the test is processed.
Since 2009, the CAP has advocated for a regulatory framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists. In 2015, the CAP proposed a legislative framework for LDT oversight that used a stratified approach to effectively balance regulation by the FDA and CMS without stifling innovation or patient access to LDTs. The proposal focused FDA oversight on the tests that currently have the least transparency and highest potential patient risk. The CAP’s proposal employed a three-tiered, stratified model that authorizes a role for third party accreditors and classifies tests based on their overall complexity and potential risk to patients based upon three categories: low, moderate, or high risk. In addition, analytic and clinical validation of LDTs would have a key role in any future LDT regulation.
- 2023 CAP Comments to FDA on the LDT Proposed Rulemaking
- FDA-CAP Webinar on Emergency Use Authorization
- May 2022 message from President Volk on LDTs
- 2022 Update Webinar on LDTs and the VALID Act
- 2022 Frequently Asked Questions on Oversight of LDTs
- 2022 CAP Letter on VALID Act
- 2021 CAP Letter on VALID Act
- 2019 CAP letter on VALID Act
- 2017 CAP letter on DAIA
- 2017 FDA Discussion Paper
- CAP letter on companion diagnostics
- Summary of 2015 legislative proposal
- 2015 statement for the House Energy and Commerce Subcommittee on Health
- 2015 letter to the FDA commissioner
- 2010 comments on FDA oversight of LDTs