1. Medtech Insight
  2. >>Digital Technologies

'Excellence' In Health-Software Design: US FDA Taps Nine Firms To Figure Out What That Means

 
• By David Filmore

The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.

DigitalHealth_1200x675

Engagement between FDA and the consumer tech world advanced Sept. 26 with the US agency's announcement of the participants selected for its nascent digital health "Pre-Cert" pilot program.

Companies Selected For FDA Pre-Cert Pilot
  • Apple: iPhone/iPad/Apple Watch health apps could begin to venture into FDA regulation territory.
  • Fitbit: Leader in fitness wearables
  • Johnson & Johnson: Diversified medtech...

Apple, FitBit and Samsung were three of the nine companies chosen for the program, in which firms agree to interact with FDA and provide data to help establish certification standards...

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 Digital Technologies

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
• By Barnaby Pickering

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

More from Medtech Insight

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
• By Barnaby Pickering

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Execs On The Move: 12-23 May 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.