Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

New FDA Regulations Streamlining the Governance of Combination Products Detailed in New White Paper

September 10, 2013 By Microtest Laboratories

New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled Combination Products 3.0: Applying the New FDA Regulations in 2013 discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

“Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities,” according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, “21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products,” revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

According to Dr. Richter, “the FDA’s new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, Combination Products 3.0: Applying the New FDA Regulations in 2013, from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Related Articles Read More >

Verily Study Watch
Verily says its Study Watch could identify heart failure risk
A child using a medical device at home.
Device design takes the spotlight among 2024’s top health tech hazards
These 11 medical device inventions are the best of 2023, Time magazine says
A photo of a Best Buy Geek Squad employee helping a chronic care patient with a remote monitoring device.
Device manufacturers have an unexpected ally for at-home health care
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe