• where experts go to learn about FDA
  • In Vitro Diagnostic Devices

    • OHT-7’s Q1 2021 Report Card on EUA ReviewsApril 14th, 2021

      During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed: We have also really have ramped up our decisions. So we are currently over the last week averaging about nine …

    • Shhh! It’s a Secret! FDA is Not Providing Key Details in the EUA TemplatesApril 12th, 2021

      We have previously posted about the heartache and anxiety that is the EUA process (here).  Companies are waiting months for feedback from FDA and are frequently given comically short timelines for response. Another layer in this onion of poor management is the growing gap between the …

    • FDA Grants Marketing Authorization to BioFire’s Multiplexed COVID Test – Lines Have Been DrawnMarch 26th, 2021

      On March 17, 2021, FDA granted BioFire Diagnostics’ De Novo, making it the first COVID assay originally authorized on a temporary basis for this public health emergency to be given permanent access to the US market. While FDA has only released the signed letter affirming …

    • Potential False Results with Roche Molecular Systems’ SARS-CoV-2 AssayMarch 18th, 2021

      On Friday, March 12th FDA posted a letter to healthcare providers about performance concerns regarding the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System.  This public letter appears to be the culmination of a dialogue between Roche and …

    • Area of Interest Funding – “There’s Always Money in the Banana Stand”March 3rd, 2021

      If you tuned in to FDA’s weekly Virtual Town Hall Meeting on February 10th, 2021 you would have seen a short presentation by Toby Lowe (CDRH/OHT-7) describing a recent funding announcement from HHS OASH, Office of Assistant Secretary for Health, and the DoD. This “Area …

    • FDLI Publishes New Book on IVD Regulation Co-Edited by HP&M’s Jeffrey Gibbs and Allyson MullenJanuary 28th, 2021

      While receiving less public attention than some other types of health care products, in vitro diagnostics (IVDs) have for years been playing an increasingly important role in health care.  The COVID-19 pandemic has highlighted what has long been the case: IVDs are indispensable to public …

    • 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 …