We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Stakeholders Seek More Clarity on FDA’s Combo Products Guidance

Stakeholders Seek More Clarity on FDA’s Combo Products Guidance

May 28, 2019

Industry stakeholders told FDA that they want to see more clarity on its guidance on combination product premarket reviews.

Issued in February, the draft guidance explained how FDA centers would make approval pathway decisions for drug-device combination products.

The FDA considers that if a product’s primary mode of action is a device, then the product would be submitted under a medical device pathway with CDRH; whereas a product with a drug primary mode of action would be submitted under a drug pathway with CDER or CBER.

AdvaMed said the draft guidance was too general in parts and that the FDA should clarify that product centers have responsibility and authority for product-specific premarket decisions. AdvaMed flagged several examples of inconsistency in the guidance and asked the agency to “qualify its generalization with the caveat that center staff have authority for premarket review decisions, and they make these decisions on a case-by-case basis.”

The association said the guidance should also include a pathway for the use of a device master file for combination products. It said it is not uncommon for drug companies to partner with device companies for containers or delivery devices for drug or biologic products, and a medical device master file “provides a mechanism for the device company to maintain trade secrets or confidential commercial information.”

View today's stories

Medical Devices Regulatory Affairs

Upcoming Events

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

  • 08Mar

    Medical Device Cybersecurity: The Regulatory Landscape and How to Defend Your Practices During an Inspection

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Boston Scientific’s Single Use Ureteroscope Gets FDA Clearance

  • Gilead’s Trodelvy Gets Expanded Approval in Breast Cancer

  • AI Software to Improve Echocardiogram Images Gets FDA Clearance

  • Rocket Pharmaceuticals Gets RMAT Designation for Danon Disease Gene Therapy

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing