In Vitro Diagnostic Devices

With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April (here).  We take this date with a grain of salt given the frequency with which these …

On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices.  Weighing in at nearly 60 pages, the comments detail extensive flaws …

For more than three decades, FDA has claimed that the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here).  In this post, we summarize the purported basis …

As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs).  There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the …

It’s the moment we’ve all been waiting for, dreading, anticipating . . . . Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd.  The proposed rule has a …

FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices.  The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy …

On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home.  According to the announcement, enabling patients to access medical devices beyond …

The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn.  In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to …

As we discussed in our prior post, the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form.  It is also going to take some getting used to in terms of process.  As most in the device industry know, …

Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s.  The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).  With 18 years’ experience, we have developed a pretty good system for preparing 510(k) …

A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive …

It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here).  While the potential mitigating impact of the “grandfathering” clause on laboratories currently …

Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak.  The program began …

On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) declared the outbreak of monkeypox virus a public health emergency (see announcement here).  On September 7, 2022, the Secretary of HHS declared that “circumstances exist justifying the authorization of emergency …

We are almost three years into the public health emergency as a result of the COVID-19 pandemic, and still only have 19 rapid antigen tests authorized for at-home use in the United States. The primary barrier to bringing new antigen tests to market has been …