Do I have to register with the FDA and pay fee?

A

aadel

#1
Hi everyone,

I represent a new company that is working toward establishment a PL brand of home test kits (drug tests). If my research is correct, then this falls under the category of Class I - 510(K) Exempt.

With that said, my question is based on the following:

If we are outsourcing the product and having a manufacturer from overseas create, apply label, and package the product, and then shipped to the states where we will simply distribute. Do we have to register with the FDA and pay the fee of ($4.6k), or is there another route that exists? We really want to address any necessary documents in order to avoid any conflicts with US Customs.

Any advice is appreciated, thank you very much.

- aadel
 
Elsmar Forum Sponsor

AnaMariaVR2

Trusted Information Resource
#2


Overview of IVD Regulation

What is Establishment Registration?
Establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register with the FDA.
Registration provides FDA with the location of medical device manufacturing facilities and importers.
Registration of an establishment is not an approval of the establishment or its devices by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance is required before a device can be placed into commercial distribution in the U.S.
Device Registration and Listing

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

Congress has authorized FDA to collect an annual establishment registration fee for device establishments. A detailed list of the types of device establishments that are required to register and pay the fee can be found at "Who Must Register, List and Pay the Fee". The establishment registration fee is not eligible for a reduced small business fee.
The schedule of annual registration user fees for fiscal years 2017 through 2018 follows:

Year FY 2017 FY 2018
Fee $3,382 $4,624
Title 21 CFR Part 807
Who Must Register, List and Pay the Fee
 
A

aadel

#3
I just looked over more documentation regarding my situation and I firmly believe that I am qualified only as a domestic distributor of the private label brand. I am not involved in the production and distribution of the product. I have reached out to my manufacturer and was informed that they have FDA 510(K) clearance and that I should not face any conflicts with U.S. Customs. Hopefully they are right...

Cheers,

aadel
 

JeantheBigone

Quite Involved in Discussions
#4
Somebody in the US has to register and list as an "initial importer" if they are not the final customer.

If the overseas manufacturer is shipping directly to customers, then they will have to add each and every customer to their listing.

If instead they are shipping to distributors who in turn ship to customers, then those distributors must register and list as "initial importers."

The deciding factor is whoever takes title of the devices when they enter the US.

Hope that helps!
 

Wes Bucey

Quite Involved in Discussions
#5
So my question (sorry, mercenary consultant here) is:
"Is this $4,000+ fee going to make or break the deal?"
If so, maybe this distribution deal isn't lucrative enough to take the deal.
 
Thread starter Similar threads Forum Replies Date
M Register, list and pay the Device Facility User Fee with FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
L Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
S Federal Register - Software Reclassification (MDDS) - Final Decision by FDA yet? Other US Medical Device Regulations 3
T FDA Federal Register - 2013 date for 60601 3rd Ed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
S How to register class IIA medical device accessories EU Medical Device Regulations 1
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H REACH Registration Requirements - Who is required to Register REACH and RoHS Conversations 1
Z Do we need a Risk Register for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
T ISO 9001:2015 vs AS9100D - Register to one or both Standards? Manufacturing and Related Processes 10
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Get information into English about medical devices register in Serbia Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risk Register template as per ISO 27001:2013 wanted IEC 27001 - Information Security Management Systems (ISMS) 9
C Should we register to ISO 9001:2008 or ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
A Legislation Register in Dubai (Free Zone) ISO 14001:2015 Specific Discussions 1
I Feedback on an Environmental Aspects and Impacts Register Miscellaneous Environmental Standards and EMS Related Discussions 5
V What is the importance of a Risk Register? FMEA and Control Plans 3
L Examples of a Legal Register - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
S MDR (Master Document Register) for Planning of Documents in Process Engineering Document Control Systems, Procedures, Forms and Templates 2
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
I What information do you place in a "register"? Quality Manager and Management Related Issues 2
I Is a Register of Signatures Required by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom