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Post: Classification of Device (Topic#3830)

Rob S
Beginner
Posts: 1

04-22-08 09:55 AM - Post#4691

I working with a company that is in the process of manufacturing a medical device but it has no predicate device for 510K submission. It is not a high risk device and is definetely not a Class III so it shouldn't require a PMA. How should we proceed with market approval with the FDA?

John
John Cuspilich, Sr. Consultant
Posts: 229
John

05-13-08 06:53 AM - Post#4719

In response to Rob S

Best way to start is to visit http://www.fda.gov/cdrh/devadvice/
Here, you will find step-by-step instructions on filing and classification.

Sincerely,
John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc.
jcuspilich@auditing.com
jcuspilich@fda.com
856-596-2333 - 866-GXPNews

AndrewAllenMC
Beginner
Posts: 3

07-20-09 10:47 PM - Post#5602

In response to John

Doesn't CE Marking deal with Medical Devices as well?

Andrew

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