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, …
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 …
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 …
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 …
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 …
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 …
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 …
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™ …
On December 18, FDA released its draft guidance, “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”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 …
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 …
On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning …
Over its ten years the FDA Law Blog has posted numerous stories about FDA's regulation of laboratory developed tests (LDTs) (see, e.g., here, here, and here) Yet, the story of FDA's efforts to regulate LDTs goes back even further than the FDA Law Blog, to …
In late November, FDA announced that it would not be finalizing the 2014 draft LDT Guidance. The Agency had, however, done a significant amount of work regarding the draft guidance and evaluating the regulatory framework for lab tests. In an effort to document the work …
By Allyson B. Mullen & Jeffrey N. Gibbs – All this year, FDA had signaled it intended to finalize the guidance for Laboratory Developed Tests (LDTs). On Friday November 18, 2016, FDA abandoned the effort, stating that it will not provide the requisite 60-day notice to Congress …
By Allyson B. Mullen – On April 1, FDA issued an updated draft guidance regarding the policies and procedures for Emergency Use Authorizations (EUAs). The EUA procedures cover all types of medical products including drugs and biologics (e.g., vaccines and therapeutics) and devices (e.g., personal protective …
