While this author needs no excuse to listen to Van Halen, one surprising source of inspiration came while reviewing the body of guidance documents issued by CDRH in the last year. While CDRH issued between 38 and 48 new draft or final guidance documents in …
On October 9, 2025, the U.S. Senate voted in favor of including a revised version of the BIOSECURE Act as an amendment to the National Defense Authorization Act (NDAA). The bill was not included in the version of the NDAA passed by the U.S. House …
Secretary of Health and Human Services Robert F. Kennedy, Jr., did not hide his disdain for FDA prior to his appointment, stating: FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating …
On September 29, 2025, FDA announced that it would be expanding its use of “Early Alert” communications for potentially high-risk device recalls, having determined that the pilot of this program was a success. The pilot program, initiated November 21, 2024, sought to minimize the time …
On September 19, 2025, FDA published in the Federal Register a final rule reverting the regulatory definition of “in vitro diagnostic products” (IVD products) in 21 C.F.R. § 809.3 to the text as it existed prior to the effective date of the May 2024 LDT …
On August 6, 2025, the Office of Information and Regulatory Affairs (OIRA) published a notice that FDA has rescinded the Laboratory Developed Test (LDT) Final Rule that was vacated earlier this year by the U.S. District Court for the Eastern District of Texas. The rescission …
At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …
At midnight on Friday, May 30, 2025, the government’s deadline to notice an appeal from the U.S. District Court for the Eastern District of Texas’s decision vacating the LDT Rule lapsed without the government doing so. This means the District Court decision stands, with no …
There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. This scrutiny was enhanced after the Fourth Circuit’s ruling in United States v. Mallory, 988 F.3d 730 (4th …
On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDA’s Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDA’s view that LDTs are medical devices subject to FDA regulation under the …
As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. FDA requires a new 510(k) clearance when a modification to …
On September 27, 2024, in U.S. v. California Stem Cell Treatment Center, Inc., a Ninth Circuit panel unanimously held that a stem cell clinic’s Stromal Vascular Fraction (SVF) procedure constitutes a “drug” under the Food, Drug and Cosmetic Act (FDCA) and does not meet the …
On August 22, 2024, FDA hosted a webinar to provide further guidance on the regulatory requirements it intends to apply to Laboratory Developed Test (LDT) developers in Stage 1 of the phaseout policy of the LDT Final Rule – during which FDA has said laboratories …
On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional disapproval under chapter 8 of title 5, United States Code” of FDA’s Final Rule to regulate Laboratory Developed Tests (LDTs). These …
The most recent version of the BIOSECURE Act (the “Act”) was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with …
