Current and Future Oversight and Regulation of Laboratory Developed Tests

1 Hour and 15 Minute Video | ARNOLD & PORTER LLP

Laboratory-developed tests (LDTs) continue to thrive and play a significant role in clinical decision making and patient management, particularly in the personalized medicine environment. With laboratories regularly introducing innovative LDTs the trend towards swift expansion and commercialization will likely continue. LDTs are currently regulated under CMS’s Clinical Laboratory Improvements Amendment (CLIA); however, the FDA has expressed interest in regulating tests developed and then offered by labora¬tories. Various stakeholders including industry manufacturers, laboratories and physicians have strong opinions regarding the FDA’s regulation of these new tests as the effects of the potential regulation will mean significant changes for all involved.

  • Current LDT regulatory framework
  • Analyzing related cases and enforcement actions
  • Research Use Only (RUO) final guidance
    • RUO and IVD status determinations
    • Clarity into “intended use”
  • Compare/contrast CMS and FDA approaches to regulation


Participants that will find this webinar most beneficial will be those involved in diagnostic companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory
  • Legal

This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.







Paul Rudolf, MD, JD

Dr. Paul Rudolf has significant experience in both Medicare and FDA legal, regulatory and policy issues, particularly those relating to counterfeit drugs and radiofrequency identification technology as applied to pharmaceuticals and medical devices. He also is widely recognized for his experience with coverage, coding, and reimbursement issues for hospital and physician payment systems under the Medicare payment systems.



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Abeba Habtemariam


Abeba Habtemariam is a member of the firm’s FDA and Healthcare practice group. She provides advice to pharmaceutical and medical device manufacturers on a range of regulatory matters under the Food, Drug, and Cosmetic Act and the Public Health Service Act, including cGMP compliance, regulation of clinical research, promotional compliance matters, regulation of medical device software, internal compliance strategies, and responses to FDA inspections and government investigations.

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