Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Contract Manufacturing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • Suppliers
    • The Big 100
      • Archive – The Big 100 (2018)
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • Leadership
    • Women in Medtech
    • 2020 Winners
    • 2019 Winners

Fifth round of medtech user fee talks set to begin soon

February 19, 2021 By Nancy Crotti

Every five years, the FDA, the medtech industry and the public sit down and hammer out how the agency should spend the money it collects in fees from medical device developers seeking approvals and clearances.

The agency also uses the Medical Device User Fee Amendment (MDUFA) to set fees for biologics license applications, 513(g) requests for information and de novo requests.

Negotiations on MDUFA V were scheduled for April 2020 but were waylayed by the pandemic. Following an initial stakeholder meeting in October, the FDA now says the virtual monthly meetings may begin in March. Congress must pass by MDUFA V by September 2022, when the current user fee law expires.

Before Congress can reauthorize the amendment, the FDA must consult with the regulated industry and make recommendations to lawmakers about its goals for the process of reviewing device applications. The agency issued its official invitation today to interested parties to register for virtual monthly meetings where they can try to influence the direction of the amendment. Registration deadline is February 26, 2021.

A couple of those interested parties told Medical Design & Outsourcing what they want out of MDUFA V.

Medical device companies have invested $1.2 billion in user fees set by MDUFA IV, according to Medical Device Manufacturers Association (MDMA) executive director Mark Leahey. Some of the goals laid out in the current law weren’t met before COVID-19 hit and others were compounded by the pandemic, Leahey added. MDMA would like the FDA to fill jobs that the current user fee program funded, and decide what to do with the $100 million reserve fund of user fees that hasn’t been spent, he noted.

“Let’s get an assessment of all the investments we’re currently making and all of the dollars we’re currently paying, and if those investments haven’t been made, let’s start there,” Leahey said. “And if there are some additional, incremental, targeted investments that we could make to improve the process, we’re happy to consider those.

“For us it’s just consistency and transparency,” he said.  “The last user fee agreement, we surveyed our members and 95% of our members said the quality of the journey is more important than the quickness of the journey.”

Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA), said these negotiations, which also include the Department of Health and Human Services, are “very involved.”

“We want to make sure that building off of MDUFA (IV), the last agreement that we created, we want to maintain the current performance levels and maintain the appropriations,” Hope said. “And (where) the appropriations currently are at, the majority — slightly majority share — comes from the FDA. And so we want to maintain that ratio so that we don’t have an inverse of the manufacturers put it in more resources than the FDA does.”

 

 

Related Articles Read More >

Q-Collar
FDA authorizes Q-Collar to help protect athletes’ brains
Pfizer BioNTech vaccine
Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
catheter-recalls-2020
The worst catheter-based device recalls of 2020
New FDA medtech cybersecurity chief expects guidance to debut this year

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.

MDO Digital Edition

Digital Edition

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

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

Enewsletter Subscriptions

Tweets by MedTechDaily

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
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Medical Tubing + Extrusion
  • MedTech 100
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertising
  • Subscribe to Enewsletter
  • Subscribe to Print Magazine
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our Device Talks Tuesdays Discussion

Copyright © 2021 WTWH Media, LLC. All Rights Reserved. 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
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Contract Manufacturing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • Suppliers
    • The Big 100
      • Archive – The Big 100 (2018)
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • Leadership
    • Women in Medtech
    • 2020 Winners
    • 2019 Winners