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  • In Vitro Diagnostic Devices

    • Join Top Genomics and Regulatory Experts to Analyze the Law Governing Genomics Research, Data, and Clinical CareOctober 22nd, 2020

      Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy lag behind science, and the law governing genomics remains unclear – which means the time …

    • In Support of the New HHS Policy Barring FDA from Premarket Review of LDTsAugust 31st, 2020

      On August 19, the Department of Health and Human Services (HHS) announced that FDA shall no longer conduct premarket review of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act and implementing regulations (FDCA).  The crux of the statement is this:  “the …

    • FDA, Testing, and COVID-19: A “Mid-Mortem”August 25th, 2020

      From the start of the COVID-19 pandemic, access to accurate and reliable testing to identify patients exposed to SARS-CoV-2 or infected with COVID-19 was identified as a critical element of an effective public health response.  Testing is needed to diagnose individuals with active symptoms, enable …

    • HHS Reverses Its Position and No Longer Requires EUAs for COVID-19 LDTsAugust 20th, 2020

      In a jaw-dropping move, HHS  announced today that, effective immediately, FDA will no longer require premarket review of laboratory developed tests (LDTs)—including LDTs to detect the virus that causes COVID-19—absent notice and comment rulemaking.  HHS is rescinding all guidance documents and informal statements of policy concerning …

    • New FDA Policy Significantly Limits Serological TestingApril 13th, 2020

      During the COVID-19 pandemic, there is widespread agreement that one of the most important steps the government can take is to enable widespread testing of patients.  Many experts have cited the lack of access to a sufficient number of tests as a fundamental flaw in …

    • Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts LegislationOctober 21st, 2019

      A warning letter issued earlier this year by the Food and Drug Administration (FDA) to Inova Genomics (Inova) prompts some reflections on where things stand now with the regulation of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FDCA).  An LDT, …

    • Advertising Laboratory Tests: Change on the Way in MarylandApril 12th, 2019

      The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing.  As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories.  Two bills were introduced earlier this year to address …

    • New Efforts to Expand Access to Laboratory Tests in MarylandFebruary 6th, 2019

      Readers who work with laboratory tests are likely aware that such tests can be subject to regulation by FDA, CMS, and individual states. A few state laws, particularly those in Maryland, New York, New Jersey, and Rhode Island, currently constrain how some laboratory tests are …

    • FDA Formally Recognizes First Public Genetic Information DatabaseDecember 25th, 2018

      For the first time, FDA formally recognized a public database containing information about genes, genetic variants, and their relationship to disease.  FDA announced its formal recognition of the genetic variant information in Clinical Genomic Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data, a database …

    • Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about OthersNovember 21st, 2018

      On October 31, 2018, FDA announced that 23andMe could market its Personal Genome Service Pharmacogenetic Reports test (the “23andMe test”) as a direct-to-consumer test for providing information about genetic variants that may be associated with medication metabolism.  The 23andMe test was reviewed using the de …

    • HP&M Weighs in on FDA’s “Technical Assistance” to Proposed IVD LegislationNovember 2nd, 2018

      It’s been about two months since FDA issued its Technical Assistance (TA), and the buzz around FDA’s draft legislation has not died down. In fact, FDA has continued to promote the proposal, including a speech by Commissioner Gottlieb’s Chief of Staff, Lauren Silvas, in late …

    • FDA’s IVD TA: It’s Not Just Technical AssistanceAugust 14th, 2018

      Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics.  We have written about this topic multiple times (see our list at the end of this post). The focus of many …

    • CMS Finalizes National Coverage Determination for Next Generation Sequencing TestsMarch 20th, 2018

      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a new National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests.  The granting of the new NCD resulted from the FDA – CMS Parallel Review of Foundation Medicine, Inc.’s FoundationOne CDx™ …

    • Are There Only Two Types of Tests in Clinical Studies – Legally Marketed or Investigational? Maybe, according to FDA’s Draft Guidance for Investigational IVDsDecember 26th, 2017

      On December 18, FDA released its draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.” This is the latest guidance from the Agency on the relationship between in vitro diagnostic (IVD) products and therapeutic products. You will recall that the Centers jointly issued the …

    • FDA Opens A Door For Consumer Genetic TestsDecember 4th, 2017

      On February 19, 2015, FDA granted de novo authorization to 23andMe for genetic tests for autosomal recessive traits that are offered directly to consumers (DEN140044).  Nearly three years later, FDA has proposed a pathway that opens this avenue further.  In a statement on November 6 …