When medical devices are sold domestically, can they be sold in Puerto Rico?

SGquality

Quite Involved in Discussions
#1
I know the answer is a "Yes" but just wanted to confirm that when medical devices are sold domestically, that includes Puerto Rico as well, and that no additional approvals are required to sell a medical device in Puerto Rico?

Thank you!
 
Elsmar Forum Sponsor
#3
https://webcache.googleusercontent....virgin-islands.html+&cd=1&hl=en&ct=clnk&gl=th

Here's one answer of "Yes" - can't find the original Cove thread, but the cached version seems okay. That thread points out that the regulations regarding the language of labeling specifically mention Puerto Rico and that devices there may be labeled in Spanish only.

The legal rationale is as follows:

1. The U.S. Constitution states that Federal law is the supreme law of the land and any state or territorial law that conflicts with federal law is invalid.
2. Along the line of the cases interpreting this clause, courts have held that where a federal law (including regulations) that thoroughly regulate an area or the law says that the feds have the exclusive ability to regulate it (such as medical devices), then states or territories cannot regulate them. This is called Federal Preemption.
3. So just as states cannot regulate medical devices, neither can Puerto Rico, which is under federal jurisdiction.

So the legal theory matches the Cove thread and generally accepted result that - Yes - that as far as the feds are concerned your device can be marketed in all 50 states, including Puerto Rico and the U.S. Virgin Islands ... and Guam. But the Marshall Islands ... no idea.

But this doesn't fully clarify the question of whether there are additional incidental requirements - for example a Prop-65-like thing.
 

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Chrisx

Involved In Discussions
#4
But some states like Louisiana still insist on having their own registration requirements :mad:! I guess no one has bothered to challenge the legality of such additional barriers to inter-state commerce.
 
#5
But some states like Louisiana still insist on having their own registration requirements :mad:! I guess no one has bothered to challenge the legality of such additional barriers to inter-state commerce.
They impose additional requirements on the device? I'd need to see that to believe it.
 

Pjservan

Involved In Discussions
#6
From a consumer perspective- I have lived in Puerto Rico and still have family that does- they are the same rules. Labeling in Spanish is mostly optional or a means to better communicate with the consumer (aka liability).
 

Watchcat

Trusted Information Resource
#7
some states like Louisiana still insist on having their own registration requirements
They impose additional requirements on the device? I'd need to see that to believe it.
Umm. it's Louisiana. :D I'm not familiar with the requirements, but I would guess it is more like a business registration and license, with a fee and perhaps taxes, and that the money is the whole point. They could care less about the device. This is apparently becoming more common, including in some municipalities, struggling to make ends meet. However, I think some other states (want to guess?) have established more extensive regulations, but presumably not anything "in conflict with" federal law.
 
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