The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > Other US Medical Device Regulation Topics
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Click the graphic above.
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
class ii medical device, fda (food and drug administration), fda classification, fda unified registration and listing system (furls)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 30th March 2012, 05:14 PM
ryno fan ryno fan is offline
Involved in Discussions

 
Registration Date: Mar 2012
 
Posts: 34
Thanks Given to Others: 0
Thanked 1 Time in 1 Post
Karma Power: 13
Karma: 15
ryno fan has less than 100 Karma points so far.
Question FDA Rules on Medical Device Classification Listings?

Hello,

1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?

2. Is there a requirement for manufacturers to list their marketed medical device accessories?

Thanks for the help.

Sponsored Links
  #2  
Old 30th March 2012, 07:29 PM
JeantheBigone JeantheBigone is offline
Involved in Discussions

 
Registration Date: Nov 2011
Age: 56
 
Posts: 63
Thanks Given to Others: 39
Thanked 57 Times in 29 Posts
Karma Power: 17
Karma: 306
JeantheBigone is appreciated, and has over 300 Karma points.JeantheBigone is appreciated, and has over 300 Karma points.JeantheBigone is appreciated, and has over 300 Karma points.JeantheBigone is appreciated, and has over 300 Karma points.
Re: FDA Rules on Medical Device Classification Listings?

If the accessories have a product code then they will have to be listed. If they do not have a product code then as far as I know there is no way t list them

http://www.fda.gov/MedicalDevices/De.../ucm053185.htm
Sponsored Links

  #3  
Old 30th March 2012, 10:46 PM
ascherp ascherp is offline
Involved in Discussions

 
Registration Date: May 2009
Location: Netherlands
 
Posts: 43
Thanks Given to Others: 22
Thanked 32 Times in 18 Posts
Karma Power: 26
Karma: 170
ascherp is appreciated, and has over 100 Karma points.ascherp is appreciated, and has over 100 Karma points.
Re: FDA Rules on Medical Device Classification Listings?

All devices marketed in the United STates have to be listed on FURLS, including all class 1 devices. Class 2 and 3 devices need to be listed as well, but you would additionally need a premarket notification number, such as a 510(k) or PMA number, to do so.

Some accessories have their own product code. Look up NBH as an example.

If an accessory does not have its own product code it is usually classified according to the device it is used with. So it may be class 1, but could be class 2 if intended for use with a class 2 device.

You can find information on listing requirements on the Medical Device home page of the FDA under the links Device Registration & Listing and Device Advice. I also suggest going to the FDA home page and then following the links Training/Continuing Education and CDRH Learn for the online courses available on basic topics like registration and listing.
  #4  
Old 31st March 2012, 10:20 AM
MIREGMGR MIREGMGR is offline
Appreciated Information Resource

 
Registration Date: Aug 2008
Location: SE Michigan, USA
 
Posts: 3,349
Thanks Given to Others: 1,160
Thanked 2,491 Times in 1,528 Posts
Karma Power: 413
Karma: 27406
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.MIREGMGR is appreciated, and has over 1700 Karma points.
Re: FDA Rules on Medical Device Classification Listings?

Quote:
In Reply to Parent Post by ryno fan View Post

1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?

2. Is there a requirement for manufacturers to list their marketed medical device accessories?
I agree with the comments above on question 2, but an additional comment: the key question regarding an "accessory" is not what you call it or whether you market it as an accessory or a device. It's whether it objectively meets the definition of a device. If it does, then it's a device and has to be listed.

As pointed out, some products that do not meet the definition of a device nonetheless have to be listed because there is a specific ProCode for that accessory type.

On question 1, the answer depends on your definition of "product family".

If for instance you make 500 minor dimensional and feature-detail variants of a camera drape, you could internally document that all of those products belong to your "camera drape" family. You would have a single listing for "camera drape". The key consideration is that all the product family members have the same ProCode.

You however could not group together several towel drapes, camera drapes, microscope drapes, slush machine drapes, etc. and call them a single product family, because they have various ProCodes.

There is no distinction between Class 1 and Class 2 regarding "product families". If you offer several minor variants of a product, all having the same basic description and intended use and the same ProCode, they can be a product family.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > Other US Medical Device Regulation Topics

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Classification of a Medical Device in FDA celia4237 US Medical Devices (21 CFR part 820) 15 23rd January 2014 01:11 PM
FDA Classification for Medical Device Power Adaptors (Power Supplies) yarina Other US Medical Device Regulation Topics 12 10th April 2012 12:31 AM
Medical Device FDA - Classification of a device used as an interface with a computer RickRay US Medical Devices (21 CFR part 820) 3 10th June 2011 03:51 PM
Medical Device FDA Product Classification help needed lei622 US Medical Devices (21 CFR part 820) 1 23rd April 2011 01:32 AM
FDA, Classification Rules & Medical Software Devices thisby_ US Food and Drug Administration (FDA) 3 25th February 2010 06:30 AM



The time now is 02:39 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272