Visit DOTmed at RSNA, North Hall B, Booth #6608 -- Ask about Clean Sweep Equipment Auctions

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

RSNA: Researchers use Microsoft Kinect to improve X-ray exams May also improve fluoro and CT exams

Radiology panel offers frank talk on meaningful use and coming 'tectonic shift' of 2019 merit based payment systems (MIPS)

Cell phones create medical imaging HIPAA storage and security violations: RSNA Radiology and IT leaders discussed access issue related to rapid adoption of EHRs

RSNA product showcase View all the latest products in this month's special RSNA Product Showcase

Interval Timer and the development of X-rays This month in medical history

RSNA: Siemens gets FDA nod for world's first twin robotic X-ray system, the Multitom Rax First system to acquire 3-D natural weight-bearing images

GE leadership highlights hospital interoperability challenges: RSNA What’s next now that radiologists are out of the dark corners of the reading rooms?

No one-size-fits-all when it comes to CT dosing: BC Technical Exploring the line between dose reduction and diagnostic success

Panel calls for radiologists to 'take a seat at the table' in shaping new payment model RSNA 2015

RSNA: Raising the bar on breast tomosynthesis The benefits of C-View software for improving the new standard in breast imaging

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In July 2011, the FDA released draft guidance on how it intends to regulate those applications.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

Fully integrated PACS, RIS and Voice Recognition at an affordable price

We fit our RIS/PACS to match your workflow, rather than the other way around! Call us at 866-949-7227 or click here to visit our website & see our Advanced Mammography Workstations & Mammography Tracking System built into RIS

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 ©2001-2015 DOTmed.com, Inc.