LDT Regulatory Framework & Notification Guidance Explained

We recently released a blog post announcing expected changes for laboratory developed tests (LDTs). The majority of these changes relate to the premarket and post-market regulation of LDTs due to advances in technology and business models and their evolution. The FDA is proposing the following draft guidance documents as the first step in addressing concerns related to Laboratory Development Tests (LDTs) today:

Framework for Regulatory Oversight of Laboratory Development Tests (LDTs)

The proposed framework will give the Food and Drug Administration (FDA) authority over premarket and post-market Laboratory Development Tests (LDTs) regulation by using a risk-based approach. Under this guidance, regulation of LDTs might include the removal of unsafe tests from the market and require more stringent quality standards. This guidance defines a Laboratory Development Test (LDT) as a type of in vitro-diagnostic intended for clinical use. However, under the proposed framework, direct-to-consumer tests do not qualify as a LDT.

Risk-Based Framework

Regulatory changes will begin with the highest-risk tests identified by the Food and Drug Administration (FDA) . High-risk tests may include tests used to identify personalized treatments for high-risk conditions like cancer and heart disease. Laboratory Development Tests (LDTs) defined as moderate-risk will likely be subject to full FDA regulation in accordance to existing Class II and III device requirement.  Class I devices or low-risk LDTs will receive varying levels of enforcement discretion.

Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)

The second guidance document is intended to provide additional direction for Medical Device Reporting (MDR) related to Laboratory Development Tests (LDTs). The Framework Guidance helps to categorize risk and define what tests require compliance. The Notification Guidance puts an emphasis on registration and listing in lieu of notification as well as adverse event reporting requirements. This will require clinical laboratories to notify the FDA when they are manufacturing LDTs.

Medical Device Reporting

In addition, the Notification Guidance puts an emphasis on Medical Device Reporting (MDR). This guidance will require laboratories with Laboratory Development Tests (LDTs) have similar quality and reporting requirements as medical device manufactures do. This includes MDR and reporting corrections or device removals. Adverse event reporting is another emphasis within this guidance. The Food and Drug Administration (FDA) will look to MDR regulations for LDTs according to device class.

Preparing For Change

Changes will be phased in starting with the highest-risk tests over and estimated nine years of implementation. However, high and moderate-risk Laboratory Development Tests (LDTs) registration and listing as well as adverse event reporting are set to begin six months after the Draft Framework Guidance is final. You can prepare for these upcoming changes now by having an understanding of how these regulations will impact your laboratory and knowing what processes you will need to implement to be sure that your laboratory will comply. It is clear that premarket quality assessment and post-market reporting will be paramount for laboratories moving forward.Have questions or need advice preparing for these changes? Colaborate can help!

by Kevin Hunter