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510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

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510(k), fda (food and drug administration), puerto rico, us virgin islands
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  #1  
Old 27th April 2010, 05:25 PM
aoldendo

 
 
Posts: 32
Caution 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

Hi there,

I am looking for some statement on the FDA's website that 510(k) approval covers marketing clearance for Puerto Rico and the U.S. Virgin Islands.

Does anyone know a.) if the above statement is true and b.) where such statement may be located on the FDA's website or in any of their official briefings?

Thank you much.

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  #2  
Old 28th April 2010, 05:43 AM
Stijloor's Avatar
Stijloor

 
 
Posts: 14,652
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

Quote:
In Reply to Parent Post by aoldendo View Post

Hi there,

I am looking for some statement on the FDA's website that 510(k) approval covers marketing clearance for Puerto Rico and the U.S. Virgin Islands.

Does anyone know a.) if the above statement is true and b.) where such statement may be located on the FDA's website or in any of their official briefings?

Thank you much.
Can FDA experts help?

Thank you!

Stijloor.
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  #3  
Old 28th April 2010, 07:00 AM
yana prus's Avatar
yana prus

 
 
Posts: 145
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

Quote:
a.) if the above statement is true
Premarket approvals and notifications for the medical devices in USA, including Puerto Rico are under the FDA jurisdiction, so the answer is yes.

there is a specific FDA regulation regarding labeling of the devices sold in Puerto Rico:
21 CFR 801.15(c)33 says that a device is misbranded under section 502(c) of the Act unless:
“All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.”

Last edited by yana prus; 28th April 2010 at 07:36 AM.
Thank You to yana prus for your informative Post and/or Attachment!
  #4  
Old 28th April 2010, 12:40 PM
aoldendo

 
 
Posts: 32
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

yana,

Thank you for the helpful post! That is exactly the information we're in need of today.
  #5  
Old 3rd January 2012, 06:05 PM
fadler1

 
 
Posts: 1
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

So, just to confirm.................
A U.S. manufacturer must have FDA clearance to sell an IVD product to Puerto Rico?
  #6  
Old 8th October 2012, 08:50 AM
tibon74

 
 
Posts: 76
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

Hello!

Are there medical device regulation in Puerto Rica and U.S. Virgin Islands?
Does FDA approval is enough ? What can I do for products only EC marked ?

Thanks !!!!
  #7  
Old 8th October 2012, 10:20 AM
isoalchemist

 
 
Posts: 198
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

FDA Clearance and Listing is the Key. CE marked items have no standing as far as medical devices without the FDA clearance, just the same as an US approved device without a CE in Europe.
  #8  
Old 8th October 2012, 10:30 AM
tibon74

 
 
Posts: 76
Re: 510(k) Approval Good for Puerto Rico and the U.S. Virgin Islands?

thanks. So, Do I need to register FDA approved products in Puerto Rico and U.S. Virgin Islands? the FDA approval integrates these countries ?
We have products which is not FDA approved but only EC marked. What can I do to register them in these countries (Puerto Rico and U.S. Virgin Islands) ?

thanks
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