• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

FDA Selects Apple, Fitbit, Samsung, Others for Digital Health Pre-Cert Pilot Program

by HITC Staff 09/26/2017 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

FDA Recalls McKesson's Anesthesia Care for False Patient-Matching

Today, the U.S. Food and Drug Administration (FDA) announced it has selected Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Google’s Verily to participate in the FDA’s new digital health per-certification pilot program. The FDA selected the final nine companies for the pre-cert pilot program based on several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. More than 100 companies submitted entries to join the pilot program.

FDA Pre-cert Digital Health Pilot Program Overview

The FDA launched the Pre-cert pilot program on July 27, as part of the agency’s Digital Health Innovation Action Plan to foster digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures). The pilot program will focus on looking at the software developer or digital health developer first, instead of traditionally looking primarily at the product.

After reviewing the systems for software design, validation and maintenance, the FDA will determine whether the company meets quality standards and if so, to precertify the company. With the information gathered through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program. The FDA is also considering, as part of the pilot program, whether and how, precertified companies may not have to submit a product for premarket review in some cases.

As part of the pre-cert digital health pilot program, all nine selected companies are required to:

– Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI

– Collect real-world post-market data and provide it to FDA

– Meet with FDA for real-time consultation

– Be available for site visits from FDA officials

– Provide information about the firm’s quality management system

“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said FDA Commissioner Dr. Scott Gottlieb in a statement. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”

FDA will hold a public workshop in January 2018 to report on and review their initial findings, as well as provide pubic updates via the pilot program webpage as well as through stakeholder meetings. Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: pre-cert digital health pilot program

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

 Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Selecting the Right EMR: A Practical Guide to Streamlining Your Practice and Enhancing Patient Care

Featured Interview

Virta Health CEO: GLP-1s Didn’t Kill Weight Watchers, Its Broken Model Did

Most-Read

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

CMS Finalizes New Interoperability and Prior Authorization Rule

CMS Proposes 2026 Physician Fee Schedule Rule: Boosting Primary Care, Cutting Waste, and Modernizing Payments

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

Beyond SaaS: How Agent as a Service is Transforming Healthcare Automation

New Strategies Needed: No Surprises Act and the Challenges for Payors with Provider Data Inaccuracies

Samsung Acquires Xealth to Accelerate Connected Care Vision

Samsung Acquires Xealth to Accelerate Connected Care Vision

AI Dominates Digital Health Investment in First Half of 2025

Rock Health Report: AI Dominates Digital Health Investment in First Half of 2025

Moving Beyond EHRs: What Lies Ahead for Healthcare Digitization?

AI Agents vs. Chatbots: Understanding Agentic AI’s Role in Healthcare

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |