dismiss

Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

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 Pediatrics
SEARCH
Current Location:
>
> This Story


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

 

advertisement

 

Parts And Service Homepage

GE sued for allegedly 'freezing-out' ISOs in anesthesia equipment maintenance Lawsuit claims monopolistic practices

MITA publishes QMS standard for servicing of imaging devices First standard dedicated to servicing of medical imaging devices

Varex Imaging and H+P Advanced Technology to build carbon nanotube company Expect to see products come out in two-to-three years

Varex Imaging expands service offering to Europe, releases new tube and detector line at ECR Provide technical and logistical support for installations

Probo Medical acquires Trisonics Now offers an extensive ultrasound service division

MITA's remanufacturing white paper recalls 'Groundhog Day' movie: IAMERS A call for forward thinking and community awareness

MITA proposes framework for defining 'service' versus 'remanufacturing' Also points to the need for quality management systems to be implemented

Is there life after EOL for medical imaging equipment? Ken Hable of Technical Prospects discusses why the concept of 'end of life' is a falsehood

Merry X-Ray acquires Conquest Imaging Ultrasound repair leader joins growing imaging ISO

New FDA draft guidance on X-ray equipment addresses access to manuals An update to guidances issued 30 years ago

FDA extends deadline for device servicing docket comments

An editorial by Robert J. Kerwin

The U.S. Food and Drug Administration has extended the deadline for submitting written comments to its docket concerning guidance for Medical Device Servicing. Initially set for Friday, January 25, 2019, the FDA is adding an extra month for stakeholders to make their voices heard, closing the docket on February 25.

The FDA request for comments follows publication by FDA, in the fall 2018, of a white paper on "Servicing vs. Remanufacturing" and a two-day December FDA Workshop in Gaithersburg, Maryland.

Video recordings of the December meeting have been made available on the FDA website.
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.



The FDA docket to which servicing comments may be uploaded, can be found here and should be identified as pertaining to FDA Docket 2018-N-3741.

The servicing guidance is expected to address what constitutes "remanufacturing" versus "servicing", as this was an area identified by FDA in its May 2018 Report as a subject of confusion among stakeholders. Moreover, this distinction is of importance to the day-to-day activities of servicers. To what extent will a repair of a device or a part be determined to be remanufacturing? Should an activity be determined to be "remanufacturing", the regulatory requirements imposed on manufacturers would likely apply.

The FDA Guidance is also expected to address other areas of substantial dispute between servicers and manufacturers. Among other things, it is expected that FDA will further explain manufacturer labeling requirements and what constitutes adequate device instructions. What constitutes "integral" manufacturer software, which must be provided? Is the FDA’s interpretation of what constitutes "adequate instructions" limited to delivery of a service manual? Can a manufacturer claim certain information constitutes "trade secrets" exempt from delivery to servicers, when this information may be necessary to comply with manufacturer obligations to provide adequate instructions?

Guidance documents are often prepared by governmental agencies to interpret existing laws and regulations in light of technological developments and reported areas of confusion. For 40 years there has been ongoing confusion over the extent to which manufacturers must provide information to those who service devices and who are not employed by the manufacturer.

  Pages: 1 - 2 >>

Parts And Service 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 ©2001-2019 DOTmed.com, Inc.
ALL RIGHTS RESERVED