Every US state has Medical Device Regulations beside FDA Regulations

E

export

#1
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
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
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

Staff member
Admin
#3
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 ....:confused:

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

JeantheBigone

Quite Involved in Discussions
#4
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.
 
Last edited:
M

MIREGMGR

#5
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

Quite Involved in Discussions
#6
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.
 
E

export

#7
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

Quite Involved in Discussions
#8
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
 
Last edited:
M

MIREGMGR

#9
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

Quite Involved in Discussions
#10
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.
 
Thread starter Similar threads Forum Replies Date
R Not every INCIDENT report will lead to a corrective action EU Medical Device Regulations 6
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R In a software development company: Is every bug reported by the customer a complaint? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
U SI 13 - Not Every Process Requires an Efficiency Measure IATF 16949 - Automotive Quality Systems Standard 1
Howard Atkins MSAs are now required on every feature of the control plan - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 13
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Interpretation or Definition of ‘Once Every 5 Days’ ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Defect Rate for asking for an RMA - Company wants an RMA for every defect found Supplier Quality Assurance and other Supplier Issues 10
A Is normal for FORD EU ask for the PSW every year APQP and PPAP 5
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
J Is it sufficient to send in my instruments for calibration every second year? Manufacturing and Related Processes 2
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
A Personal names in docs - Goes against every documenation practice I know! Document Control Systems, Procedures, Forms and Templates 30
D Anyone Practicing Approval Signatures on Every Page of a Doc? ISO 13485:2016 - Medical Device Quality Management Systems 2
S Conduct Customer Satisfaction Survey for every submitted Bid? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Run a batch every year to revalidate the validated condition? Qualification and Validation (including 21 CFR Part 11) 4
O Is a full Internal Audit cycle every year required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A Is it mandatory to revise MSDS every three years? ISO 14001:2015 Specific Discussions 3
L Does every document on a project require a document number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Audit Design Process every Surveillance Audit - AS9104 Requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Ajit Basrur 10 Things Extraordinary People Say Every Day Coffee Break and Water Cooler Discussions 5
K Autoclave Log - Do we have to monitor the usage for every load? General Measurement Device and Calibration Topics 3
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
A Addressing every clause in ISO 17025 ISO 17025 related Discussions 1
N New to ISO 9001 - NCR for every defect? Nonconformance and Corrective Action 5
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Are signatures required on every page of a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
K Customer issues invalid SCAR and Chargeback every March Customer Complaints 6
F Is every activity required to be mentioned in BSC strategy map ? Quality Tools, Improvement and Analysis 1
C Does every procedure need to be included within a policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A Shall we raise SCAR/CAR for every defect as per our current procedure? Nonconformance and Corrective Action 4
Q 510K Checklist that considers every Design Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
V Do I need dimensionals performed for PPAP for every revision change? APQP and PPAP 2
T Living Documents which change every day - Control or Uncontrolled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Drawing Review Records Required for every Drawing (Print)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Process Objectives and Metrics - Should every documented process have objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Is a Nonconformance Report required for every Customer Complaint? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C BMU=CMC for every Calibration? ILAC Policy Clarification Measurement Uncertainty (MU) 3
K Must every CCP (Critical Control Point) have a (documented) procedure? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom