When medical devices are sold domestically, can they be sold in Puerto Rico?
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supadrai
Lawyer
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.
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.
supadrai
Lawyer
But some states like Louisiana still insist on having their own registration requirements! 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.
Watchcat
Trusted Information Resource
Umm. it's Louisiana.
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.
There it is all laid out for you:
PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
Louisiana is not on that list...
PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
Louisiana is not on that list...
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