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
Current Location:
> This Story

starstarstarstarstar (2)
Log in or Register to rate this News Story
Forward Printable StoryPrint Comment




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

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

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

FDA extends deadline for device servicing docket comments One more month for equipment stakeholders to make their voices heard

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New FDA draft guidance on X-ray equipment addresses access to manuals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 editorial by Robert J. Kerwin

On December 17, 2018, the FDA published a draft guidance in the Federal Register for industry and FDA staff that addresses, among other things, manufacturer responsibilities to provide adequate instructions to undertake compliant installations of diagnostic X-ray systems, including access to operating software.

The Guidance, entitled “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment”, also addresses general labeling, record-keeping, product reports and additional assembly requirements. When final, the Guidance will supersede the FDA Guidance issued in 1989.
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.

A federal agency "guidance" is frequently a compilation by which it updates agency interpretations of existing regulations and guidances as well as applicable law in light of industry developments. Since the 1989 FDA Guidance was first issued there have been many advances including the expansion of software for device operations and the widespread use of service keys and cybersecurity protections.

The draft guidance addresses only the requirements that apply to diagnostic X-ray equipment under the electronic products section known as the Emitting Products Electronic Product Radiation Control Program (EPRC). FDA has advised in that connection that it intends to amend its performance standards to harmonize many of its requirements with those of the International Electrotechnical Commission standards.

Providing instructions to assemblers, purchasers and others
An area of frequent concern is access to adequate instructions. The guidance provides that adequate instructions must be provided by which the specific technical specifications of the equipment and any necessary radiological safety precautions may be disclosed. Manufacturers of components listed in 21 C.F.R. 1020.30(a)(1) are required to provide assemblers with these instructions at a cost not to exceed the cost of publication and distribution.

The guidance notes that the instructions to be supplied by the manufacturer must “provide specifications for other components that are compatible with the component to be installed when compliance with the component or system depends upon compatibility.” The specifications may describe physical characteristics of compatible components and/or may list, by manufacturer’s name and model designation, specific components that are compatible, consistent with 21 CFR 1020.30(c) and 1020.30(g).

  Pages: 1 - 2 - 3 >>

Parts And Service Homepage


Greg Hackworth

FDA draft guidance on X-ray equipment

January 07, 2019 04:54

FDA is making it harder than it has to be. Put it in writing and enforce it.

The way it should be: Manufacturers will provide all tech manuals, software, and passwords to maintain equipment. If software is available to make the repair go quicker, but it can be repaired without the additional software, manuf will not be required to provide software or password.

Point is, if I buy a piece of equipment, I should have the right to repair it myself or contract the OEM. I should not be required to attend OEM training in order to get passwords or software.

Log inor Register

to rate and post a comment

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, Inc. Copyright ©2001-2019, Inc.