Clinical laboratories face a complex regulatory landscape, including multiple federal and state regulators. HPM has significant experience representing clinical laboratories on a variety of legal, regulatory, and compliance issues, including those with novel technology (e.g., methods, tests, next generation sequencing, various “omics”), algorithms, and biomarkers.  We are committed to helping clinical laboratories bring their tests to patients and healthcare providers, and navigate a changing regulatory landscape.

Our services:

  • Laboratory Developed Tests (LDTs)
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification and compliance
  • FDA regulatory compliance
  • Marketing and labeling, including test reports
  • State licensure and regulation
  • Direct-to-consumer tests
  • Companion diagnostics
  • Complementary diagnostics
  • Clinical research contracts and institutional review board (IRB) compliance
  • Contractual and transactional arrangements
  • Informed consent
  • Promotional materials