Every US state has Medical Device Regulations beside FDA Regulations

[export]

Hi all,
Every US state has its own medical device regulation beside FDA regulation. I can not search the link health dept of each state. And state regulation is much different and independent to federal regulation? Thanks

 

[somashekar]

Re: Every US state has Medical Device Regulation in ev

Hi all,
Every US state has its own medical device regulation beside FDA regulation. I can not search the link health dept of each state. And state regulation is much different and independent to federal regulation? Thanks

Is it not the state regulation PLUS the Federal regulation ... ?

 

[Ajit Basrur]

Hi all,
Every US state has its own medical device regulation beside FDA regulation. I can not search the link health dept of each state. And state regulation is much different and independent to federal regulation? Thanks

Interesting question ....

I havent heard about this. Are you refering to any of the Inter-State commerce related issues ?

 

[JeantheBigone]

You are correct, and right now it is complicated.

Many but not all US states regulate medical device manufacturers. What is worse, it is not always the same agency in each state which does the regulating, and the laws can be very different. This grew out of regulation of drug distributors and also in part because some states feel that the FDA is not providing sufficient oversight to device manufacturers.

DISCLAIMER: The list below is not complete, I am currently working on getting a comprehensive list but this often involves calling people at various states for clarification so I am ab out halfway through. Also it is subject to change as the laws of individual states can also change.

A few states currently do not regulate device manufacturers:
VT, NY, OH, NM, MN, ND, OR

Some states have establishment regiatration for device manufacturers only if they are located in-state:
TX, GA, MA, PA, NH

Some states require a separate license if the device manufacturer sells directly to patients:
MS, GA, NH, NV

MO requires a license if the company is selling to anyone other than patients.

Some states require a license if the manufacturer's products are distrubuted into the state in any way:
LA, ID, NH, CT

Most states require registration and/or permit if the device contains a drug.

Many states require a permit if the device is considered DME and the company is selling to patients.

In some cases it makes a difference if the device manufacturer uses a distributor, in some cases it doesn't.

States generally use the term "Legend device" to describe the type of device which they regulate. This term refers to the "legend" present on devices cleared by the FDA "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician"

If you want to check whether a state regulates medical device manufacturers, try looking for the state "Board of Pharmacy" since this is most often the agency responsible for registration, permitting and licensing.

Also a very good resource can be found here:

http://www.hida.org/AM/Template.cfm?Section=Home&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=13594

But be careful, as of today this report is 18 months old and a lot can change. OR for example has proposed a law requiring all prescription device manufacturers to register, so this state can go from no registration to required registration overnight at any day.

Edited to add:
I also find this list helpful as a starting point to find the state agencies that might be responsible for licensing and permitting medical device manufacturers. It applies to drugs, but most often whichever agency regulates drug distributors and manufacturers also regulates device manufacturers and distributors.
http://www.sentrybps.com/gmp-facility/licenses_and_registrations/

Disclaimer: I have no affiliation with any company or organization associated with the links posted.

 

[MIREGMGR]

When I last talked with FDA about this issue, particularly in regard to a conflict between a particular state regulation and FDA's rules, the view expressed to me was that in the event of such a conflict, FDA regards such state regulations as pre-empted by federal law. Of course, a state might see things differently, but I'd be surprised if a state Attorney General would see it as a good use of resources to get into a jurisdictional fight (which would be heard in a federal court) with FDA and the federal Justice Department over whether an otherwise-properly-behaving medical device maker should be singly or doubly regulated.

 

[JeantheBigone]

Well the current status is that a state can and will fine and/or shut down a device manufacturer who does not follow state rules. I've had this happen with a foreign manufacturer who wanted to ship their products wholesale into one of the more restrictive states. Their distributor simply refused to take delivery until the manufacturer was properly licensed.

As far as state level inspections go, many states opt not to (my guess is this has to do with sending a signal about how hostile the business climate is.) See for example here.
http://www.bizjournals.com/tampabay...b=1276488000^3485751&s=industry&i=health_care

Licenses, permits, registrations go from $100-$600. I think states are using this as a way to generate revenues.

 

[export]

Thank JeantheBigone for helpful inf. FDA regulate both domestic and foreign manufacturer of medical device but state regulation does not say clearly about foreign facility. I know many usa dental lab use offshoring and it seems that foreign labs do not meet any trouble when coming into any sate, no customs clearance and no need permit from state health authority.Is that right?

 

[JeantheBigone]

The state regulations do not differentiate between out of state and out of the US. They also do not make exceptions for non-US manufacturers.

For example, Pennsylvania requires registration from manufacturers if they are in-state. If a manufacturer is not in Pennsylvania, it doesn't matter if they are in Ohio or France, they are out of state.

Dental laboratories are a grey area.

As far as I know they are not (yet) regulated at the Federal level but there are rumors that this might change.

Registration is not required for domestic laboratories
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.65

but is required for foreign laboratories
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.40

http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4182b1_01_NADL%20Letter.pdf

This might also be helpful
http://www.nadl.org/lib//FDARegulations/PowerPointLaboratoryObligations.pdf

At the state level again laws can be different. I have not made a thorough study of state regulation of dental laboratories, but I did notice when reading many state regulations that there are exemptions for manufacturers if they are producing custom devices intended for a specific individual. Some state however do require registration of in-state dental laboratories. I refer to NADL who has put together a clickable map as a resource.

http://www.nadl.org/stateboards/stateboards.cfm

 

[MIREGMGR]

My employer has been a device maker for 35 years, with products distributed both directly and indirectly via large OEMs into every US state. Products made by us are used in most US hospitals. We have never been contacted by any US state regarding regulation of device distribution, and to the best of my knowledge neither have any of our OEM customers.

My observation is that state regulation enforcement is focused on devices that are labeled Rx Only and are sold directly to consumers. None of our devices are sold directly to consumers.

 

[JeantheBigone]

My employer has been a device maker for 35 years, with products distributed both directly and indirectly via large OEMs into every US state. Products made by us are used in most US hospitals. We have never been contacted by any US state regarding regulation of device distribution, and to the best of my knowledge neither have any of our OEM customers.

My observation is that state regulation enforcement is focused on devices that are labeled Rx Only and are sold directly to consumers. None of our devices are sold directly to consumers.

I think in general you are correct, the focus is on consumer protection. So devices sold to hospitals are less likely to be regulated, as are those which enter the state through distributors. Still, a lot can change in 35 years, which I'm sure you know better than I do. The current regulatory patchwork at the US state level appears to be related to the incidents which led to the Medical Device Safety Act - this is my opinion, not a hard fact.