The FDA’s new rule for laboratory developed tests (LDTs), unless overturned through litigation (see here), by legislation, or the election, is going to have profound effects on the U.S. health care system. At this point, nobody knows all the impacts the rule will have. But …
On April 29, 2024, FDA announced its finalization of the laboratory developed test (LDT) rule. The final rule will be published in the Federal Register on Monday May 6, 2024 (here). The final rule marks another milestone in the more than three decades long battle …
We’ve been hearing for quite some time that a Final LDT Rule would likely be coming this spring, before May 1. This timing has been attributed to FDA’s desire to avoid having the rule being overturned by Congress under the Congressional Review Act. Of course, …
On February 20, 2024, FDA issued a letter to the medical device industry (link) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. Unfortunately, the letter provides little new information to guide industry conduct. While …
FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards publication as a final rule – and to a likely judicial showdown. On March 1, the Office of Management and Budget (OMB) received the draft final LDT rule for …
More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. …
On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). …
On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). Most of these reclassified tests will supposedly be infectious disease and companion diagnostic …
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 …
Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. The notice (here) indicates that FDA plans for the panel to “discuss and make recommendations on the design of …
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 of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource (eSTAR). The same template can also be used for De Novo submissions. Currently, eSTAR is voluntary for medical device De Novo submissions, but …
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 …
