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

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » FDA releases medical device user fees for 2013

FDA releases medical device user fees for 2013

July 31, 2012 By MassDevice staff

FDA logo

The FDA this week released the 2013 pricing structure for medical device review, including discounted pricing for companies with less than $100 million in annual revenues.

The fees, which represent as substantial increase from rates for 2012, were established in the 3rd iteration of the Medical Device User Fee Act agreed upon by the med-tech industry and the federal watchdog agency.

MDUFA III nearly doubles total user fees for medical device companies from $295 million over 5 years to $595 million – but the industry expects something in return.

"This user fee agreement really isn’t your father’s user fee agreement," industry lobbying group AdvaMed’s CEO Steve Ubl said the day after the Senate approved the final bill. "It’s the first user fee agreement to include goals that are focused on total review times, from the first time of submission at the agency to when the agency makes the final decision on a PMA or 510(k). The agreement for the first time includes a provision we refer to lovingly as ‘no submission left behind,’ which requires the agency to meet with companies if the agency misses a performance goal."

The FDA agreed to meet certain performance goals and undertake measures to enhance speed and efficiency in product review in exchange for the larger fees. The funding will also allow the agency to hire more than 200 full-time-equivalent workers over the course of the 5 years, according to an FDA notice.

The measure offers discounted rates for companies which qualify as a small business, and firms with less than $30 million in gross sales and receipts may qualify for a waiver for their 1st PMA.

"MDUFA III is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives," according to the agency. "Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market."

The fees for 2013 are as follows (small-business fees in parentheses):

PMAs: $248,000 ($62,000)
Panel-track PMA supplements: $186,000 ($46,500)
180-day supplements: $37,200 ($9,300)
Real-time supplements: $17,360 ($4,340)
510(k): $4,960 ($2,480)
30-day notice: $3,968 ($1,984)
Request for classification: $3,348 ($1,674)
PMA annual report: $8,680 ($2,170)
Annual establishment registration fee: $2,575 ($2,575)

 

 

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: MDUFMA

In case you missed it

  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Acutus Medical ticks up on revenue beat, missed EPS in Q2 results
  • ResMed expects steady growth over the next year
  • Ambu is letting go of 200 employees
  • Medtronic has Class I recall for low-shock risk in ICDs
  • Titan Medical to start manufacturing Enos systems later this year
  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Cardinal Health’s CFO to move up to corner office
  • Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy
  • NuVasive chief commercial officer Massimo Calafiore is stepping down
  • Preparing your medical device company for challenging market conditions
  • Dentsply Sirona replaces chief accounting officer amid internal investigation
  • Haemonetics stock rises on Street-beating Q1, raised guidance

RSS From Medical Design & Outsourcing

  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
  • FDA’s breakthrough medical device designations tally nears 700
    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
    Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing. Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR. Landec… […]
  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

August 12, 2022
DTW – Medtronic’s Mauri brings years of patient care to top clinical, regulatory, scientific post
See More >

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.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

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
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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.

Advertise | Privacy Policy