1. Medtech Insight
  2. >>Geography
  3. >>North America
  4. >>United States

'Sharing' Organizations Stay In Final Post-Market Cybersecurity Guidance

Despite pushback from industry groups on the use of information-sharing and analysis organizations (ISAOs), US FDA has kept the language the same in its final post-market cybersecurity guidance, but has removed the term "essential clinical performance."

hand touching screen with medical data

In its final post-market cybersecurity guidance published by US FDA on Dec. 27, the agency has virtually kept the language of its draft guidance the same despite some apprehension from industry groups.

The agency published a draft guidance in January that included manufacturers joining information-sharing and analysis organizations (ISAOs) that could help them pool resources and share...

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 United States

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

More from North America

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.