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

A

aoldendo

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.
 

Stijloor

Leader
Super Moderator
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.
 
Y

yana prus

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 a moderator:
A

aoldendo

yana,

Thank you for the helpful post! That is exactly the information we're in need of today. :agree1:
 
F

fadler1

So, just to confirm.................
A U.S. manufacturer must have FDA clearance to sell an IVD product to Puerto Rico?
 

tibon74

Involved In Discussions
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 !!!!
 
I

isoalchemist

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.
 

tibon74

Involved In Discussions
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
 
M

MIREGMGR

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.

The documentation that you want will refer not to an FDA statement or rule per se, but instead to higher-level definition of the applicability of the USA legal system. FDA's regulations are based on the FD&C Act, which is one of many Federal laws; so wherever US Federal law is legally applicable, FDA has authority.

In discussing this US-legal-system extent of applicability, FDA's internal "Regulatory Procedures Manual", July 2012 edition, Chapter 2, "FDA Authority" refers to that authority existing in the fifty states plus the District of Columbia, Puerto Rico, the (my note...U.S., not British) Virgin Islands, Guam, and the Northern Mariana Islands.
 
M

MIREGMGR

Do I need to register FDA approved products in Puerto Rico and U.S. Virgin Islands? the FDA approval integrates these countries ?

Any medical device or drug marketed in the US, including Puerto Rico and U.S. Virgin Islands, is subject to US FDA authority.

We have products which is not FDA approved but only EC marked.

As noted above, the CE Mark is not relevant to FDA.

What can I do to register them in these countries (Puerto Rico and U.S. Virgin Islands) ?

In general:

The marketer/manufacturer and, if relevant, the initial importer must Register annually. It's important to understand the relevant definitions (Specification Provider, Manufacturer, Contract Manufacturer, Component Maker, Initial Importer, Distributor, Private Label Manufacturing, etc.) which differ somewhat from those applicable in the EC.
The marketer/manufacturer will be subject to FDA inspection, and will be required in some cases, depending on product nature, to conform to certain FDA regulations governing design, manufacturing and marketing.
Prior to commencement of marketing, in many cases pre-market clearance must be gotten from FDA. The 510(k) process is one type of clearance.
Prior to commencement of marketing, the marketer/manufacturer must List their products.
The marketer/manufacturer and the initial importer have legal obligations in regard to post-market surveillance and timely reporting of adverse events.

This is just a brief overview. It's essential that the full scope of regulations be understood and applied as relevant.
 
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