1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Compliance

US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

 
• By Sue Sutter

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. The ruling runs counter to a decision in a similar case involving a Florida stem cell clinic.

Roadblock
FDA's bid to halt a California stem cell clinic's treatments hit a roadblock in federal court. • Source: Shutterstock

The US Food and Drug Administration’s regulatory oversight of stem cell clinics took a hit on 30 August when a California federal judge ruled that defendants’ unapproved stromal vascular stem cell treatments are not “drugs” within the meaning of the Food, Drug and Cosmetic Act.

In a ruling that comes more than a year after a bench trial, US District Judge Jesus Bernal denied the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

More from Policy & Regulation

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.