FDA proposes fiscal 2014 user fee rates

FDA proposes fiscal 2014 user fee rates

The FDA wants to raise the user fees paid by medical device companies for the watchdog agency’s review by 4.2% across the board.

The FDA’s Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren.

The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.

The fiscal 2014 rates would see PMA applications cost $$258,520 for large companies (up from $248,000), with small-business PMAs running $64,630 (up from $62,000). Applications for 510(k) clearances would cost $5,170 (up from $4,960) for large firms and $2,585 (up from $2,480) for small businesses. Set to go into effect October 1, the new fees would generate an estimated $115 million for the FDA, according to the Federal Register.

But it’s still unclear whether the agency will get to spend any of that cash now that sequestration is the law of the land. The FDA lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, due to the pact between the White House and Congress that’s designed to shave 5% off of federal budgets across the board.

Moves are afoot in Congress to exempt the user fees from sequestration. Sen. Mark Pryor (D-Ark.) introduced a bipartisan bill last month, "A bill to exempt from sequestration certain fees of the Food and Drug Administration," to that effect, winning 4 co-sponsors including Sens. Roy Blunt (R-Mo.), Dan Coats (R-Ind.), Al Franken (D-Minn.) and Jerry Moran (R-Kan.). The measure was referred to the Senate Budget Committee, which is unlikely to take it up before the August recess this week.

The Senate move follows a similar bid in the House of Representatives 2 weeks ago. That bill, the "FDA Safety over Sequestration (SOS) Act," introduced by Reps. Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.). There were 30 co-sponsors of the House bill as of yesterday.

Here’s a comparison of the new user fee schedule for fiscal 2014 with the user fee rates for this fiscal year:


Application type Fee for FY2013 Fee for FY2014 (proposed) Percentage increase Small business fee FY2013 Small business fee FY2014 Percentage increase
510(k) $4,960 $5,170 4.2% $2,480 $2,585 4.2%
513(g) $3,348 $3,490 4.2% $1,674 $1,745 4.2%
PMA, PDP, PMR, BLA $248,000 $258,520 4.2% $62,000 $64,630 4.2%
panel-track supplement $186,000 $193,890 4.2% $46,500 $48,473 4.2%
180-day supplement $37,200 $38,778 4.2% $9,300 $9,695 4.2%
Real-time supplement $17,360 $18,096 4.2% $4,340 $4,524 4.2%
BLA efficacy supplement $248,000 $258,520 4.2% $62,000 $64,630 4.2%
Annual report $8,680 $9,048 4.2% $2,170 $2,262 4.2%
30-day notice $3,968 $4,136 4.2% $1,984 $2,068 4.2%

RSS From Medical Design & Outsourcing

  • BRILAMET research project brought to successful conclusion: Precision laser-cutting technique optimized for thick metal sheets
    Using lasers to cut sheet metal is something that has typically been handled in the realm of CO₂ and fiber lasers, although this may not be the case for much longer. Diode lasers are increasingly emerging as the light source of choice for a large number of applications, as can be seen from the BRILAMET […]
  • Mobidiag and Unilabs enter into agreement over use of Amplidiag product line for molecular gastrointestinal diagnostics
    Mobidiag, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, and Unilabs, a diagnostics service provider, announced an agreement covering the supply of Amplidiag products over the next four years for Unilabs in Sweden and Norway. The Amplidiag product line covers six diagnostic products for various gastrointestinal infections, […]
  • Quick work keeps dental implants in place among women with osteoporosis
    As natural as aging is, it can tend to feel like a downward spiral. As the years increase, bone mass and strength decrease. Teeth can fall out, and the drugs and surgery designed to return things to normal may actually make bone related issues worse. Osteoporosis is a common problem for women who have gone […]
  • Cyberdyne CEO has severed spines on his agenda
    Editor’s Note: This article is from Bloomberg.com‘s Natasha Khan. Cyberdyne Inc.’s CEO, Yoshiyuki Sankai, is researching ways to repair damaged body tissue. The 57-year-old scientist’s vision: to treat patients with spinal injuries by using stem-cell related technology to repair nerve connections and robotic suits that aid movement. Sankai’s company is setting its sights on better […]
  • Teknor Apex to showcase wide range of PVC compounds for medical devices at Medtec China
    Building on its international leadership role as a supplier of medical-grade PVC compounds, Teknor Apex Company has developed flexible and rigid formulations that address the special needs of device manufacturers. The company will highlight these capabilities at Medtec China 2015. “Teknor Apex produces or markets medical-grade PVC compounds in China, Singapore, Europe, and the United […]
  • The Raspberry Pi eco-system goes interstellar with the new Raspberry Pi Sense HAT
    Newark element14 has globally launched the latest addition to the expanding ecosystem of Raspberry Pi accessories, the Raspberry Pi Sense HAT, as featured in the ‘Astro Pi’ space mission. The Sense HAT will enable enthusiasts to control the same hardware used in space. The Sense HAT attaches to the Raspberry Pi board, and can be […]
  • CommScope completes acquisition of TE Connectivity’s Telecom
    CommScope Holding Company, has completed its previously announced acquisition of TE Connectivity’s Telecom, Enterprise and Wireless businesses, a leader in fiber optic connectivity for wireline and wireless networks. The all-cash transaction, valued at approximately $3 billion, strengthens CommScope’s position as a leading communications infrastructure provider with deeper resources to meet the world’s growing demand for network […]
  • SPI awards IKO Prosthetic Creative System the Student Design International Design Excellence Award
    SPI: The Plastics Industry Trade Association congratulated IKO Prosthetic Creative System for winning the SPI Student Design Award, part of the Industrial Designers Society of America’s (IDSA’s) International Design Excellence Awards (IDEA) program. The award was presented to IKO, an innovative, youth-focused prosthetic design company led by Chicago-based designer Carlos Torres, by SPI’s Senior Director of […]
  • New assay could revolutionize diagnosis and treatment of life-threatening disease
    Invasive Fungal Disease (IFD) is an emerging global health problem associated with high mortality rates in severely immunocompromised patients, such as those undergoing intensive chemotherapy or stem cell transplantation, and in patients suffering immune compromising conditions such as AIDS. The most common causative agents of this disease have been identified as Candida and Aspergillus species, […]
  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]

Leave a Reply