EchelonDx’s IVD/LDT Compliance, Strategy and IT Support teams have been closely monitoring the FDA’s Final Rule regarding Laboratory Developed Tests.

Our FDA In-Vitro Diagnostic experts have shared several insights below.

  1. This new rule applies to “IVDs offered as LDTs.” Our experts can help determine whether your IVD is affected by the FDA’s Final Rule.
  2. Phaseout Policy Overview:
    • May 6, 2024: The Phaseout Policy began, requiring medical device reporting, correction and removal reporting, and quality system compliance within one year. EchelonDx’s integrated teams can set your teams up to meet these new requirements.
    • Part 2 of the Phaseout Policy: This phase dictates establishing registration & device listing, labeling requirements, and investigational requirements. Our CRO experts can ensure your team has the correct data from RCTs and clinical studies.

Depending on your LDT, the enforcement policies may or may not affect your IVD. EchelonDx’s expert IVD development teams can help you determine the requirements for your IVD.

Why EchelonDx?

Unlike other providers EchelonDx is an acknowledged expert in Genetic (NGS) diagnostic development at the molecular level. This includes algorithm development, statistics, target identification and validation straight on through to regulatory approval pipeline dev/build. This expertise is combined with no kidding regulatory know how.

We understand your business at the deepest level.

Meet Our Team

Brad Lomas Vice President Business Development

John Burke Chief Science Officer and Founder

More About EchelonDx

EchelonDx is the leading diagnostics focused CRO and advisory firm specializing in AI, NGS and diagnostic pipeline development including clinical and regulatory affairs for the pharmaceutical, medical device and biologics industry. Our deep referenceable experience in bringing genetics based diagnostic tests to approval and to market makes us the leading partner to bring medical device and biotech innovation from development to market.

Learn More About EchelonDx