News

STAT5hOpinion
Five priorities to remake the FDA in a time of deep uncertainty
Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...
JD Supra1d
Addressing Data Integrity Challenges in Medical Device Submissions
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
360Dx1d
Final Rule Kaput, FDA Still Has Options for Exerting Authority Over Lab-Developed Tests
The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.
JD Supra1d
Post‑Chevron Spotlight: Federal Court Nixes FDA Rule Reclassifying Laboratory Services as Medical Devices
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the ...
MedTech Dive1d
A judge blocked the FDA’s plan to regulate LDTs. What now?
One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...
When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
AI in Software as Medical Devices (SaMD): Navigating Patent and Regulatory Challenges in the US, Europe
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...
National Law Review6d
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
Medical Device Network17d
FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system
Credit: Saylakham / Shutterstock. The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological ...
Forbes21d
RFK Jr.'s 10,000 Health Job Cuts: CDC, FDA, Medicare And Medicaid Services Reportedly Affected
who claims Americans’ food is packed with unsafe ingredients and chemicals—will not affect drug, medical device, or food reviewers or inspectors, HHS said. HHS said the cuts will likely be ...
FierceBiotech22d
FDA's novel medical device clearances slow to a crawl
Once determined to be safe and effective, their clearances open up new regulatory pathways for ... to make updates to previously approved devices. An FDA spokesperson told Fierce Medtech that ...
Roll Call22d
Targeting FDA user fees would leave agency gutted, experts say
The reauthorization of FDA’s prescription drug, generics, biosimilar and medical device programs was included in the fiscal 2023 appropriations act, and they are set to expire on Sept.