SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

Millions are dying from treatable conditions worldwide because of poor access to surgery With $420 billion investment, progress can be made by 2030

New technique reduces the effect of tumor motion during proton therapy But challenges stand in the way of bringing it to the clinical setting

More premies driving neonatal market in Europe: report Despite being "saturated" the European infant care solutions market is growing due to a rise in preterm births

MR-guided focused ultrasound is a possible “cost-effective strategy” for uterine fibroid treatment OHTAC recommends the procedure based on economic analysis

Rayence gets FDA nod for RU-3000 Digital Universal Radiography System First U-arm marketed by Rayence in U.S.

Imaging informatics accelerates change-agent role in ACA transition How imaging informatics quickly transformed the change-agent role in ACA translation

Siemens' tomosynthesis add-on for mammography platform scores FDA approval Provides a wide angle 50 degree angulation arc

Study finds correlation between gun wound patients and stock market performance Hospitals may now have a new incentive for monitoring national economics

Los Alamos National Laboratory creates ultra-low-field MRI for developing countries and battlefields Radio signals 50 miles away can interfere with these detectors

IBA's ProteusPLUS will be first proton therapy system in the Netherlands The two-gantry configuration will be installed in partnership with University Medical Center Groningen

Fred Upton (R-Mich.)

GOP seeks clarity on taxing smartphones, tablets, apps as medical devices

by Loren Bonner , DOTmed News Online Editor
Republicans on the House Energy and Commerce Committee, including chairman Fred Upton (R-Mich.), wrote to U.S. Food and Drug Commissioner Dr. Margaret Hamburg on March 1st asking her to clarify the uncertainly surrounding regulating mobile medical applications — a rapidly growing market. GOP lawmakers are concerned that smartphones, tablets and apps will be regulated as medical devices and therefore manufacturers will be subject to the excise tax under President Obama's health care law.

In July 2011, the FDA released draft guidance on how it intends to regulate those applications. The FDA has the authority under the Food Drug and Cosmetic Act to regulate certain products that meet the definition of a medical device, and applications more or less have the ability to turn mobile platforms into medical devices. In the draft, the FDA stated that they would likely regulate medical mobile apps that transform a device into a regulated medical device. However, they did explain that the manufacturer would not be considered a medical device maker unless they were marketing the product as being intended for medical users.

Story Continues Below Advertisement

Dunlee - Design, Manufacture & Distribution of CT & Rad X-Ray Products

Dunlee manufactures replacement tubes for more CT systems than any other company in the industry. Philips, GE, Picker, Shimadzu, Siemens, Elscint or Toshiba replacement tubes for all popular systems. Call 800.238.3780



Although the FDA is focused on 'intended use,' authors of the letter stated that they are "concerned about the potential of 'actual use' becoming a factor in the future."

They give the example of draft guidance issued by the FDA last year concerning commercially distributed in vitro diagnostic products. In this instance, the FDA indicated that 'actual use' would be a factor in their analysis of 'intended use.'

"If FDA determines that certain smartphone, tablet, or mobile medical apps are devices for the purposes of the FDCA [Food Drug and Cosmetic Act], it raises the possibility that they would also be subject to new taxes under the PPCA," stated the letter.

A 2.3 percent excise tax to medical device manufacturers was included in the Affordable Care Act to help raise roughly $30 billion over 10 years to offset the cost of the law.

In addition to clarification, the letter also asked the FDA to provide an update on when final guidance will be released. The FDA has been gathering public comments on the draft guidance since it was released in July 2011.

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED