In vitro diagnostic assays (IVDs) are some of the most complex regulated (and in some cases unregulated) devices on the market today.  IVD manufacturers and laboratories running these tests need attorneys with specialized knowledge to understand the complicated and evolving regulatory framework of FDA regulation, CLIA, and state licensure.

IVDs are also playing an increasingly important role in the pharmaceutical development process. The availability of companion and complementary diagnostics will play a growing role in the drug approval process.  Because of our expertise in the regulation of both diagnostics and pharmaceuticals, HPM is able to assist IVD and pharmaceutical clients on issues relating to companion diagnostics. We can help clients develop a regulatory strategy that addresses the requirements for the IVD and the pharmaceutical product, and the associated commercial issues.

  • Counseling on regulatory requirements and strategy for:
    • Laboratory Developed Tests (LDTs)
    • In Vitro Diagnostic Devices
    • Research Use Only (RUO) products
    • Investigational Use Only (IUO) products
    • Analyte Specific Reagents (ASRs)
  • Assist with the pre-submission process
  • Assist with 510(k), de novo applications, and PMAs
  • Assist with postmarket compliance
  • Promotional and labeling review
Professionals

Related FDA Regulatory Categories