Pre-Bid now on 2000+ items! Our live auction is happening next Wednesday, November 2nd!

Current Location:
> This Story

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

Never Miss a Story

Sign Up For Weekly Top Stories


More Industry Headlines

Precision medicine is having a big impact on breast cancer chemo decisions: study Test distinguishes high risk of recurrence from low risk

Researchers combine X-ray with UV light for most effective cancer therapy Replacing chemo drugs with nanoparticle technology

Even without concussion, MR shows brain changes in young football players Even without major incidents, tackle football impacts brain function

PET/CT probe detects clogged arteries before atherosclerosis symptoms Disease usually doesn't announce itself until stroke or heart attack

Data Management: In the ICD-10 trenches, coding as an art and science Understanding the importance of a coding professional's work

J&J, Texas Medical Center partner to accelerate design of breakthrough medical devices The Center for Device Innovation will open in 2017

Study reviews alternatives to anesthesia for pediatric MR exams Different solutions suggested for different age groups

Survey finds slight uptick in radiation therapist positions available in the U.S. The vacancy rate of medical dosimetrists remains stable

World Medical Association taps controversial doc as chief Physician facing corruption and criminal conspiracy charges claims innocence

This Month in Medical History – Margaret Sanger and the first birth control clinic Breaking the law and changing attitudes

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In July 2011, the FDA released draft guidance on how it intends to regulate those applications.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

Experience the Future of 4K Operating Room Technology

Mult-Modality Readiness * 4K Surgical Display * Focal Point on a Single Monitor * Surgeon Control * Improved Workflow * Operational Reliability by Using Redundant Component * Architecture * Click to learn more

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.


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

Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Gold Service Dealer Program
Receive RFP/PS
Healthcare Providers
See all
HCP Tools
A Job
Parts Hunter +EasyPay
Get Parts
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
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 ©2001-2016 DOTmed.com, Inc.