Laboratory Developed Tests

Backed by the experience of our in-house consulting team, we offer a variety of services that can help you meet the global regulatory standards set by the FDA and EU legislators for laboratory developed tests.  

Unlock regulatory peace of mind

In-house consulting experience you can rely on

Comprised of seasoned professionals and industry experts, our team has the specialist knowledge required to deliver complete regulatory compliance for laboratory developed tests (LDTs). 

Whether you’re navigating the complexities of CLIA compliance or would like further insight into the current rules and regulations within the US or EU market, we can help.  

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What are laboratory developed tests (LDTs)?

LDTs are a sub-set of in vitro diagnostic products (IVDs) intended for clinical use which are designed, manufactured and used within a single clinical laboratory to meet certain laboratory requirements. 

Although the FDA has historically maintained that it has the authority to regulate LDTs as medical devices, it generally has not enforced premarket review and other medical device regulatory requirements for LDTs.

In 2023, the FDA announced a proposed rule aimed at helping to ensure the safety and effectiveness of these tests. The FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. 

The FDA is proposing this phaseout to better protect public health by helping to assure the safety and effectiveness of LDTs. If finalised, this phaseout may also foster the manufacturing of innovative IVDs for which the FDA has determined there is a reasonable assurance of safety and effectiveness.

The EU legislator is regulating laboratory developed tests for the first time with EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). As a result, its requirements apply directly to laboratories that offer tests they developed themselves.

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Why choose Apotech for laboratory developed tests?

At Apotech, we have extensive experience in helping clients develop systems that ensure compliance with global regulations – both existing and upcoming.

Here are some of the key services we can help with:

  • CLIA Compliance 
  • 510(k) Premarket Notification or Premarket Approval (PMA)
  • QMSR Regulation
  • Medical Device Reporting
  • Registration and Listing
  • EU IVDR Regulatory Compliance including Annex I, MDCG 2023-1
  • ISO 15189, ISO 13485 (7)
  • Labelling

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