dismiss

Come visit us at Booth 901 at AHRMM in Washington, DC
Mark your calendars! On August 2nd is our upcoming LIVE Clean Sweep Auction

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
> This Story


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

 

Business Affairs Homepage

GE Healthcare, Jefferson Health partner for $1 billion in efficiencies Eight-year deal will put over 100 GE staffers into 13 network hospitals

Higher upfront hospital inpatient spending reduces Medicare deaths and overall costs Figuring out what constitutes wasteful spending in health care

GE Healthcare acquires consulting firm Novia Strategies Company helped hospitals save hundreds of millions of dollars

Philips to enhance therapeutic offerings via dual acquisitions Innovating interventional procedures with Spectranetics and CardioProlific

Konica Minolta to acquire Ambry Genetics in $1 billion deal Will be 'first in a series' of precision medicine acquisitions

Commission alleges Canon's Toshiba Medical acquisition breached EU rules Fine could hit $2.9 billion

New research finds physician-hospital consolidation raises prices Horizontal and vertical integration are at play

Hologic takes FujiFilm to court over patent infringement The suit alleges that five patents in total are infringed upon

Cardiac remote monitoring firms to pay $13 million in fraud resolution Accused of billing Medicare for more costly cardiac monitoring than was needed

Survey finds most physicians view MACRA requirements as 'very burdensome' AMA offers resources to help

Workshop to be held in Maryland
on October 27 and 28

FDA announces public workshop to discuss third-party refurb docket

by Christina Hwang , Contributing Reporter
Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket.

In March, the FDA introduced a docket that sets out to specifically define terms pertaining to the non-OEM medical industry. Interest in it, sparked by safety concerns, has sent shock waves through a third-party industry eager to defend its reputation and fearful of regulations that might hurt its business.

Story Continues Below Advertisement

RaySafe helps you avoid unnecessary radiation

RaySafe solutions are designed to minimize the need for user interaction, bringing unprecedented simplicity & usability to the X-ray room. We're committed to establishing a radiation safety culture wherever technicians & medical staff encounter radiation.



For OEMs the docket is generally regarded as an opportunity to gain greater clarity about what they can and cannot be held accountable for in situations where a third-party has taken over control of their machinery.

The workshop, to be held on October 27 and 28 at the FDA's campus in Silver Spring, Maryland, will aim to move the needle on issues central to the docket:

  • Establish working definitions for third-party and (original equipment manufacturer) OEM activities.

  • Discuss benefits and challenges that stakeholders encounter, potential benefits and risks to patients/users, and failure modes of devices introduced as a result of performing activities associated with third-party entities.

  • Identify current best practices and discuss alternative methods to mitigate risks associated with performing activities associated with third-party entities.

  • Determine whether specific procedures are necessary for each activity as it relates to third-party services performed.

“FDA is currently reviewing all of the comments and will use them to inform a set of working questions designed to promote an understanding of challenges and best practices to mitigate risks associated with these activities,” said the FDA in the Federal Register.

The docket received 176 comments from a wide range of stakeholders. Look for the August issue of HealthCare Business News magazine for an in-depth report on those responses.

Business Affairs Homepage


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 ©2001-2017 DOTmed.com, Inc.
ALL RIGHTS RESERVED