Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. …
In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency. The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices …
We return to the subject of FDA’s role in effectively blocking most rapid antigen COVID tests from the U.S. market. There has not been a new rapid antigen test authorized during the past six weeks. As we mentioned in our previous post, NIH’s ITAP program was …
On November 15, HHS announced that it was withdrawing the prior administration’s policy that prevented FDA from requiring premarket review of laboratory developed tests (LDTs) without notice and comment rule making. See the prior post on this policy here. This statement comes at least six …
In our last post on Laboratory Developed Tests (LDTs), we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same …
You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID‑19 LDTs. At the time, we wrote favorably about this move. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
