SBS - The Best Value in QMS software

Is an R&D company subject to FDA regulation when licensing and not manufacturing?

#1
My company recently changed its business plan from intending to manufacture and market a medical device for the ICU, to now developing the technology and then licensing it to Partners. The Partners would then manufacture and market the product for various markets, some of which would be regulated by FDA and others. As the R&D company who is licensing the technology, will we be audited and required to submit to the FDA, or will only our Partners?

I apologize for being vague on the product details, but I don't think it is relevant to the question.

Thanks in advance for your help.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

It mostly depends on whose name the devices are going to be marketed under, i.e. who will be the regulatorily responsible Manufacturer. If it's going to be the licensees, your company will merely be a supplier - of the design. As such it won't be subject to the regulations directly, under most regulatory systems I know, but nevertheless it may still be answerable indirectly for design related issues.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#3
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
Are you this above .... ?
Then you are to register, list and pay fee
see 807.20 (a)(1)
THIS page could help you more
You will then be open to be inspected by FDA.
 
#4
Thank you for your responses.

Somashekar, Specification Developer looks like a good description.

It isn't clear though what the regulatory burden is for a Specification Developer besides registering, listing and paying the fee. Would we be subject to an FDA audit? Would there be a certification approval process with verification testing or validation requirements, etc.?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Thank you for your responses.

Somashekar, Specification Developer looks like a good description.

It isn't clear though what the regulatory burden is for a Specification Developer besides registering, listing and paying the fee. Would we be subject to an FDA audit? Would there be a certification approval process with verification testing or validation requirements, etc.?
Your company will only be a Specification Developer if it distributes the devices (made elsewhere) under its own name. Not the typical arrangement I understand as "licensing".
 
#6
Ronen, you are correct; that is not what we envision. The product would be manufactured and marketed by other companies under their own names, with us being paid a royalty for each product. We may supply one part of the system which we would probably have contract-manufactured; the marketing strategy is still in the conceptual planning phase.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
We may supply one part of the system which we would probably have contract-manufactured;
1. Is this "part" merely a component, or can it be put to use on its own, as a medical device?

2. Supply to who - manufacturers or distributors/users?
 
#8
Hi Ronen,

The product is a combination of a skin abrasion device, a glucose biosensor, a Bluetooth transmitter and mobile software to connect to a smartphone/tablet. It will be marketed as a health wellness device to allow people to use their glucose readings or trends to make better wellness decisions, but not clinical decisions. The exact language and intent seems to be critical with regard to the guidance docs.

The skin abrader could possibly be used on its own and it still remains to be seen as whether it will qualify for the dermabrasion exclusion for Class 1 devices. [On a side issue, I haven't been able to figure out how to see a listing of all the predicates of these devices (code 878.4820).] We may or may not decide to manufacture this, contract it out or allow the partners to manufacture.

The API and Encryption software would be supplied by us, while the partners would make the smartphone/tablet apps.

The biosensor and transmitter would be manufactured by the partners, but we would supply an encryption chip that makes it all connect properly.

The goal is for the product to be marketed for General Wellness, but there are several issues to clear with FDA first. Later, we would look at the hospital clinic and out-patient market for use as a CGM.

Supply would be to the manufacturers, but we also are looking at possibly supplying one of the consumables, and that could possibly be to distribution.

I hope I didn't overwhelm you with TMI.
Thanks.
 
M

MIREGMGR

#9
Your company will only be a Specification Developer if it distributes the devices (made elsewhere) under its own name. Not the typical arrangement I understand as "licensing".
Just to muddy the waters a bit, note that your business agreements should address actual regulatory responsibility as opposed to only discussing the name under which the devices are marketed...because it could be the case that your business partners would see themselves as subject to the US FDA "Private Label" exception, in which case their view would be that you are the regulatorily responsible party even though the devices are marketed with their name on the top line and your name likely not on the labeling at all.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hi Ronen,

The product is a combination of a skin abrasion device, a glucose biosensor, a Bluetooth transmitter and mobile software to connect to a smartphone/tablet. It will be marketed as a health wellness device to allow people to use their glucose readings or trends to make better wellness decisions, but not clinical decisions. The exact language and intent seems to be critical with regard to the guidance docs.

The skin abrader could possibly be used on its own and it still remains to be seen as whether it will qualify for the dermabrasion exclusion for Class 1 devices. [On a side issue, I haven't been able to figure out how to see a listing of all the predicates of these devices (code 878.4820).] We may or may not decide to manufacture this, contract it out or allow the partners to manufacture.

The API and Encryption software would be supplied by us, while the partners would make the smartphone/tablet apps.

The biosensor and transmitter would be manufactured by the partners, but we would supply an encryption chip that makes it all connect properly.

The goal is for the product to be marketed for General Wellness, but there are several issues to clear with FDA first. Later, we would look at the hospital clinic and out-patient market for use as a CGM.

Supply would be to the manufacturers, but we also are looking at possibly supplying one of the consumables, and that could possibly be to distribution.

I hope I didn't overwhelm you with TMI.
Thanks.
No, it's not too much information...

I'm only a little confused by your initial phrasing:

As the R&D company who is licensing the technology, will we be audited and required to submit to the FDA...
... while now you describe a plethora of manufacturing roles your company might assume. I'm almost tempted to say that the licensing in this case is irrelevant to the issue of being subject to FDA submissions or inspections. You should review each activity / product that you are actually going to realize carefully and separately, to see what your obligations are under each.

Regulation 878.4820 includes various product codes under it, and I think most of them are irrelevant to the specific device type you mentioned (see here for example). You probably better narrow your search to the specific product (3-letter) code.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
S Business Number versus Company ID? Canada Medical Device Regulations 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S Malcolm Baldrige Company Dashboard Quality Tools, Improvement and Analysis 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
R MDEL and company affiliate Canada Medical Device Regulations 0
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Implementing the PRRC role in a company EU Medical Device Regulations 8
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 18
qualprod Corona virus Contingency plan - What have you done in your company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Client Communication - SaaMD company Misc. Quality Assurance and Business Systems Related Topics 3
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
E Company A supplies pharmaceuticals to the MOI - Who is responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Quality Assurance in China - Developing a quality management system for a California company Misc. Quality Assurance and Business Systems Related Topics 9
S How to determine & document Organizational Knowledge of a company Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom