The Cove Business Standards Discussion Forums
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
UL - Underwriters Laboratories - Health Sciences
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
510(k), databases, furls (fda's electronic registration and listing system), guidance documents, medical device listing codes and classifications
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 27th December 2017, 04:23 AM
supadrai

 
 
Total Posts: 35
Truce Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database

Hello all,

We are a medical glove manufacturer. In reviewing our 510(k)s in the 510(k) database, one of our customers is now shown as being the Holder of one of our 510(k)s. There are no facts or documents to support them as owning any of our 510(k)s - they also appear as the Holder of many major manufacturer 510(k)s which would simply not be the case.

I suspect that they should be using the MDLs that we have generated (as Spec Developer / Foreign Exporter), but have instead generated their own MDLs using our 510(k) numbers which would indicate to the FDA that they are the presumptive owner of the 510(k), which is then reflected in the 510(k) database automatically (or without meaningful review).

Has anyone encountered this before? Any advice on how to handle? The factory is climbing up the walls and management is looking to blame someone for "losing" one of our 510(k)s. All the while, we can't be aggressive with the customer.

I suspect they've hired someone new in RA who thought they were doing the correct thing and this is probably an innocent error. But nevertheless, we need to fix the problem and I'm not sure we can rely upon the Draft 510(k) Transfer of Ownership guidance (can't post the link yet due to post count) which states we can go to the FDA in case of a dispute over 510(k) ownership.

And everyone's on vacation ...

Happy Holidays to all and thank you in advance!


Sponsored Links
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >

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
Emoticons 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
Re-registration of medical device in Russia - "changing holder" Rocke Other Medical Device Regulations World-Wide 1 17th December 2014 08:12 PM
FDA relabeler and repacker requirements for Medical devices sherley13 US Food and Drug Administration (FDA) 5 8th May 2013 11:53 AM
Have you heard about "Ample Amps" - "Miraculous Motors" - "Maxeff" ? (or Wanlass) Popeos Coffee Break and Water Cooler Discussions 10 19th December 2012 02:58 AM
OASIS Database "Certified" Suppliers Status Question Frank T. Registrars (Certification Bodies) and Registration 4 27th January 2011 05:11 PM
Draft changes from "measurements" to "indicators"? 8.2.1 Customer Satisfaction Craig H. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5 12th March 2007 05:09 PM



The time now is 11:17 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"