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

Bilingual patients have better cognitive function after stroke But it may not apply to all bilingual people

Will the future hold compact, tunable X-ray devices made of graphene? May reduce radiation dose and cost associated with current X-ray devices

Dell announces entry into health care monitor market New device is designed to meet IEC 60601-1 standard

Canadian hospital clerk who sold maternity records fined $27,000 — hospital facing $308.4 million suit From 1995 to 2014 she sold at least 14,450 records

Google Glass used to treat blocked coronary artery for first time A more economical option

UnitedHealth scaling back efforts in ACA exchanges May quit them entirely in 2017

Discover Cinematic Rendering technology A talk with Dr. Dorin Comaniciu, vice president of Siemens’ Medical Imaging Technologies

Philips' app-based ultrasound, Lumify, is available in the U.S. First ultrasound solution offered on a subscription basis

Ingestible device can measure heart and breathing rates from inside the GI tract 'An extremely tiny stethoscope you can swallow'

Bundled payments to overhaul lucrative total joint replacement surgery sector The new rule will be initially rolled out in 67 metropolitan areas in April of 2016

Budget sequestration could impact FDA device reviews

by Loren Bonner , DOTmed News Online Editor
Medical device approval processes could be severely impacted due to automatic, across-the-board spending cuts set for March 1.

According to analysts at the health care consulting firm Avalere Health, so-called sequestration would deprive the agency of critical resources needed for the timely review of important medical products. Sequestration would cut 8.2 percent from the federal budget unless Congress and the White House can agree on a way to cut spending through other means like tax reform.

Story Continues Below Advertisement

Up To 80% Off on Medical Display Monitors! Call (832) 877-1250

We are wholesaler of pre-owned and new brand name medical display monitors. We have top brand grayscale and color LCD monitors with up to 3 years warranty and at least a 30 days money back guarantee at up to 80% off MSRP. DOTmed Certified

"If you go whack the FDA budget there will be layoffs," Dan Mendelson, CEO of Avalere, told DOTmed News. "It's just the only way they can survive relative to a highly labor intensive environment."

For example, clinical trials for devices, which require FDA approval, could be impacted if the FDA lacks the resources to let the manufacturers know that the trial is unsafe and should not proceed.

"By statute, the FDA has to let them [manufacturers] know in 30 days to stop and fix something before going forward," said Lakshman Ramamurthy, director FDA regulatory policy at Avalere. "If no one is there because of confusion, then the trial will proceed because they haven't been told to stop." Post-review processes could be equally impacted, according to Ramamurthy.

In addition, sequestration sets up a rare situation for the agency where increased user fees for 2013 are collected but not available to the agency.

In 2013, new user fee rates went into effect and as a result, the FDA agreed to hire more people.

"It's ironic because all the user fee payments will continue unabated but the agency will not be able to access that money so it sets up this world where the life sciences companies have to pay but the agency does not benefit," said Mendelson.

The problem is further exacerbated by the fact that FDA appropriations for fiscal year 2013 are set at 2012 funding levels.

While the FDA will have to make its own plans in the event they face budget cuts, Avalere officials hope the FDA is prepared for what may come on March 1.


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.