• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA mandates pediatric data requirements for new medtech applications

FDA mandates pediatric data requirements for new medtech applications

January 14, 2014 By Arezu Sarvestani

FDA's final rule defines pediatric data requirements for new medical devices

The FDA this month finalized a rule requiring more pediatric patient information from medical devices going through the premarket approval pathway, even if the products are intended for adults.

The requirement, part of the Food & Drug Administration Amendments Act passed in 2007, aims to improve the identification of devices that could be used to treat children and to enhance the agency’s ability to track devices approved for use in pediatric patients.

The new rule takes effect April 10, 2014, according to a notice in the Federal Register, at which point medial device makers will be required to "include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients."

The FDA will need that data to compile an annual report that it’s required to submit to Congress, the agency said. The rule applies to requests for humanitarian device exemption, premarket approval applications and supplements and product development protocols submitted after the effective date.

Failing to provide the necessary information may result in refusal to approve the new technology, the FDA warned. The agency plans to contact applicants who have insufficient information and to work with companies to get them up to speed on the new pediatric data requirement. For companies whose applications are lacking only the pediatric info, the FDA plans to issue "approvable" letters that recognize the validity of the application in general and to request the missing information.

Filed Under: Food & Drug Administration (FDA), News Well, Pediatrics, Pre-Market Approval (PMA), Regulatory/Compliance

More recent news

  • Imperative Care has positive stroke treatment study results
  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • Intuitive demonstrates remote telesurgery capabilities with da Vinci 5
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • CVRx announces Medicare win for Barostim therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy