It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent …
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 …
We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. In response to the post, we did receive feedback from a company that had had the …
FDA has long touted the use of real-world evidence (RWE). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products …
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 March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing …
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical …
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 …
In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder, we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. FDA’s proposed rule has every hallmark of a case subject to the “major questions …
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 …
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 …
The first anniversary is always special. Janus-like, it offers the opportunity to simultaneously reflect on hitting a milestone and projecting the future. The first anniversary can also prompt a taking of stock: how well did the first year go? Recently, the over-the-counter (OTC) hearing aid rule, …
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 …
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 …
