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

Cybersecurity Expert Says eSTAR Requirement Will Push FDA, Industry In Positive Direction

 
• By Hannah Daniel

Medcrypt cybersecurity expert tells Medtech Insight that FDA requirements that launch on 1 October will push the industry as well as the agency in a positive direction.

A grey laptop sits on a wooden surface. The laptop has a blank, generic form open on the screen.
• Source: Shutterstock

Cybersecurity expert Naomi Schwartz is looking forward to October.

Beginning 1 October, the Food and Drug Administration will begin requiring electronic Submission Template And Resource (eSTAR) forms for...

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 Regulation

More from Policy & Regulation

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 
• By Amanda Maxwell

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

Warning Letters - July 2025

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