Elsmar Cove Quality DiscussionsClass 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
UL - Underwriters Laboratories - Health Sciences
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

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

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
class i medical device, fda (food and drug administration), fda classification, pma (parts manufacturing approval), premarket approval, diagnostics (general), diagnostic kits (medical), 510(k)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 13th September 2010, 02:25 PM
Bill Goss

 
 
Total Posts: 39
Question Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?

My client manufactures diagnostic kits and we believe these are class 1 medical devices. What is required prior to marketing and selling these kits as far as the FDA is concerned? Do we need to do a 510k like class 3 devices? I do not think so. Also, is there any premarket approvals required for class 1 devices?

Sponsored Links
  Post Number #2  
Old 13th September 2010, 05:08 PM
Michael Malis's Avatar
Michael Malis

 
 
Total Posts: 310
Re: Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?

Quote:
In Reply to Parent Post by Bill Goss View Post

My client manufactures diagnostic kits and we believe these are class 1 medical devices. What is required prior to marketing and selling these kits as far as the FDA is concerned? Do we need to do a 510k like class 3 devices? I do not think so. Also, is there any premarket approvals required for class 1 devices?
Hi Bill,

You need to confirm what is in these kits. They may have Class I and Class II components that may require 510(k) submission. In other words, you may have Class I product (or higher) that is not exempt from premarket notification.

Regards,
Mike
Thank You to Michael Malis for your informative Post and/or Attachment!
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
Veterinary Diagnostic Kits Regulations in South East Asia sreenu927 Other Medical Device Regulations World-Wide 8 24th July 2017 08:49 AM
IVD Diagnostic Kit Product Registration in Turkey - IVD Diagnostic Kits esh14 EU Medical Device Regulations 1 9th December 2014 07:52 AM
Risk Management Files for IVD (Invitro Diagnostic Reagent) Kits Peeter.k.varkey ISO 14971 - Medical Device Risk Management 3 10th October 2012 08:20 AM
PMA (Parts Manufacturing Approval) vs IP (Intellectual Property) Tommy68 Federal Aviation Administration (FAA) Standards and Requirements 8 16th December 2011 10:15 AM
Marking Parts Manufacturing Approval (PMA) Parts with a 8130-3 Tag quality24 Federal Aviation Administration (FAA) Standards and Requirements 9 29th July 2010 06:18 PM



The time now is 08:09 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"